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Trial Outcomes & Findings for Aerosolized Surfactant in Neonatal RDS (NCT NCT02294630)

NCT ID: NCT02294630

Last Updated: 2021-08-25

Results Overview

Since surfactant reflux is typically considered to be one of the most likely adverse events associated with the intervention, it was planned to report the number of participants specifically with surfactant reflux for this Outcome Measure

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

159 participants

Primary outcome timeframe

During and within 6 hours after end of study drug administration, expected maximum of approximately 14 hours

Results posted on

2021-08-25

Participant Flow

Of 159 enrolled and randomized participants, 149 met eligibility criteria and proceeded with treatment.

Participant milestones

Participant milestones
Measure
Dose Schedule I
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Overall Study
STARTED
37
38
35
39
Overall Study
COMPLETED
37
38
35
39
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aerosolized Surfactant in Neonatal RDS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Total
n=149 Participants
Total of all reporting groups
Age, Continuous
31.4 weeks
STANDARD_DEVIATION 3.0 • n=99 Participants
31.6 weeks
STANDARD_DEVIATION 3.3 • n=107 Participants
31.0 weeks
STANDARD_DEVIATION 3.0 • n=206 Participants
31.7 weeks
STANDARD_DEVIATION 3.2 • n=7 Participants
31.4 weeks
STANDARD_DEVIATION 3.1 • n=31 Participants
Age, Customized
GA strata · GA strata I (24-28 weeks)
7 Participants
n=99 Participants
7 Participants
n=107 Participants
8 Participants
n=206 Participants
7 Participants
n=7 Participants
29 Participants
n=31 Participants
Age, Customized
GA strata · GA strata II (29-32 weeks)
16 Participants
n=99 Participants
15 Participants
n=107 Participants
14 Participants
n=206 Participants
15 Participants
n=7 Participants
60 Participants
n=31 Participants
Age, Customized
GA strata · GA strata III (33-36 weeks)
14 Participants
n=99 Participants
16 Participants
n=107 Participants
13 Participants
n=206 Participants
17 Participants
n=7 Participants
60 Participants
n=31 Participants
Sex: Female, Male
Female
20 Participants
n=99 Participants
24 Participants
n=107 Participants
20 Participants
n=206 Participants
14 Participants
n=7 Participants
78 Participants
n=31 Participants
Sex: Female, Male
Male
17 Participants
n=99 Participants
14 Participants
n=107 Participants
15 Participants
n=206 Participants
25 Participants
n=7 Participants
71 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
4 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
37 Participants
n=99 Participants
35 Participants
n=107 Participants
33 Participants
n=206 Participants
36 Participants
n=7 Participants
141 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
2 Participants
n=7 Participants
4 Participants
n=31 Participants
Region of Enrollment
United States
37 Participants
n=99 Participants
38 Participants
n=107 Participants
35 Participants
n=206 Participants
39 Participants
n=7 Participants
149 Participants
n=31 Participants

PRIMARY outcome

Timeframe: During and within 6 hours after end of study drug administration, expected maximum of approximately 14 hours

Since surfactant reflux is typically considered to be one of the most likely adverse events associated with the intervention, it was planned to report the number of participants specifically with surfactant reflux for this Outcome Measure

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Number of Participants With Adverse Events as a Measure of Safety and Feasibility
3 Participants
8 Participants
4 Participants
12 Participants

PRIMARY outcome

Timeframe: During study drug administration, expected maximum of approximately 8 hours for adverse effects and infant comfort; need for intubation was assessed within 72 hours of study intervention.

Optimal dosing schedule was determined by preliminary evidence of efficacy (Need for intubation within 72 hours), lack of adverse effects, and overall infant comfort as assessed by bedside clinical caregivers.

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Patient Status as Evaluated by Dose Level
Need for Intubation within 72 hours
3 Participants
3 Participants
5 Participants
4 Participants
Patient Status as Evaluated by Dose Level
Adverse events - surfactant reflux
3 Participants
8 Participants
4 Participants
12 Participants
Patient Status as Evaluated by Dose Level
Overall infant comfort during AS as assessed by bedside nurse (infant most comfortable)
30 Participants
27 Participants
26 Participants
26 Participants

PRIMARY outcome

Timeframe: Within 72 hours of study intervention

It will be suggested that infants be intubated and receive MV if they met 2 or more of 5 failure criteria: i). worsening clinical signs of respiratory distress (increasing tachypnea; expiratory grunting; intercostal, subcostal, and/or sternal recession); ii). apnea treated with positive pressure ventilation (PPV) by mask on 2 or more occasions in 1 hour; iii). FIO2 \>0.5 to maintain pulse oxygen saturations 90%-95% for \>30 minutes; iv). pH \<7.2 on 2 arterial or capillary blood gases taken \>30 minutes apart; and v). partial pressure of CO2 (PCO2) of \>65 mm Hg on 2 CBG/ABGs taken 30 minutes apart.

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Short Term Efficacy as Assessed by Need for Intubation
3 Participants
3 Participants
5 Participants
4 Participants

SECONDARY outcome

Timeframe: 60±30 minutes after end of study intervention

Blood gas pH

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=34 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Blood Gas Parameters - pH
7.35 pH units for pH, mmHg for pCO2
Standard Deviation 0.05
7.36 pH units for pH, mmHg for pCO2
Standard Deviation 0.07
7.36 pH units for pH, mmHg for pCO2
Standard Deviation 0.06
7.35 pH units for pH, mmHg for pCO2
Standard Deviation 0.05

SECONDARY outcome

Timeframe: 60±30 minutes after end of study intervention

Blood gas pCO2.

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Blood Gas Parameters - pCO2
45 mmHg
Standard Deviation 8
45 mmHg
Standard Deviation 9
43 mmHg
Standard Deviation 6
45 mmHg
Standard Deviation 7

SECONDARY outcome

Timeframe: 60±30 minutes after end of study intervention

Transcutaneous Pulse oximetry

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Pulse Oximetry
95.95 percentage of oxygen saturation
Standard Deviation 3.34
96.95 percentage of oxygen saturation
Standard Deviation 5.22
97.37 percentage of oxygen saturation
Standard Deviation 3.16
97.47 percentage of oxygen saturation
Standard Deviation 3.07

SECONDARY outcome

Timeframe: 60±30 minutes after end of study intervention

Vital signs included heart rate, respiratory rate and systolic blood pressure

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Vital Signs - Heart Rate
134 beats/minute
Standard Deviation 12
142 beats/minute
Standard Deviation 14
138 beats/minute
Standard Deviation 12
136 beats/minute
Standard Deviation 12

SECONDARY outcome

Timeframe: 60±30 minutes after end of study intervention

Vital signs included heart rate, respiratory rate and systolic blood pressure

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Vital Signs - Respiratory Rate
47 breaths/minute
Standard Deviation 17
47 breaths/minute
Standard Deviation 15
46 breaths/minute
Standard Deviation 15
47 breaths/minute
Standard Deviation 15

SECONDARY outcome

Timeframe: 60±30 minutes after end of study intervention

Systolic blood pressure

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Vital Signs - Systolic Blood Pressure
54 mmHg
Standard Deviation 9
51 mmHg
Standard Deviation 8
54 mmHg
Standard Deviation 10
53 mmHg
Standard Deviation 9

SECONDARY outcome

Timeframe: Within 72 hours of study intervention

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Number of Doses of Surfactant - Aerosolized & Intratracheal
No. of doses of intratracheal surfactant - four
0 Participants
1 Participants
0 Participants
0 Participants
Number of Doses of Surfactant - Aerosolized & Intratracheal
One dose of aerosolized surfactant
10 Participants
14 Participants
13 Participants
14 Participants
Number of Doses of Surfactant - Aerosolized & Intratracheal
Two doses of aerosolized surfactant
27 Participants
24 Participants
22 Participants
25 Participants
Number of Doses of Surfactant - Aerosolized & Intratracheal
No. of doses of intratracheal surfactant - one
0 Participants
2 Participants
2 Participants
0 Participants
Number of Doses of Surfactant - Aerosolized & Intratracheal
No. of doses of intratracheal surfactant - two
2 Participants
0 Participants
1 Participants
1 Participants
Number of Doses of Surfactant - Aerosolized & Intratracheal
No. of doses of intratracheal surfactant - three
0 Participants
0 Participants
1 Participants
2 Participants

SECONDARY outcome

Timeframe: Within 72 hours of study intervention

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Pneumothorax, Pneumomediastinum or Other Air Leak
0 Participants
1 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: During and within 6 hours after end of study intervention, expected maximum of approximately 14 hours

Changes in cerebral oxygenation from baseline as evaluated at end of study intervention

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=36 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=33 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Changes in Cerebral Oxygenation From Baseline as Evaluated at End of Study Intervention
79 percentage of oxygen saturation
Standard Deviation 8
80 percentage of oxygen saturation
Standard Deviation 8
78 percentage of oxygen saturation
Standard Deviation 11
79 percentage of oxygen saturation
Standard Deviation 8

SECONDARY outcome

Timeframe: During study intervention, expected maximum of approximately 8 hours

Concentration of major surfactant lipid (PC 16:0/16:0)

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=22 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=24 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=22 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=23 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Changes in Surfactant Activity in Gastric Aspirates
10.9 ng per mg of protein
Standard Deviation 14.6
9.5 ng per mg of protein
Standard Deviation 9.2
8.8 ng per mg of protein
Standard Deviation 7.8
8.0 ng per mg of protein
Standard Deviation 8.0

SECONDARY outcome

Timeframe: at discharge

Cumulative duration of non-invasive and invasive ventilation at discharge

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Cumulative Duration of Non-invasive and Invasive Ventilation
Duration of NIV (days)
4.5 number of days
Standard Deviation 8.1
7.0 number of days
Standard Deviation 14.6
7.9 number of days
Standard Deviation 14.2
6.1 number of days
Standard Deviation 14.7
Cumulative Duration of Non-invasive and Invasive Ventilation
Duration of Invasive ventilation (days)
1.3 number of days
Standard Deviation 5.1
0.9 number of days
Standard Deviation 4.0
1.6 number of days
Standard Deviation 5.1
2.2 number of days
Standard Deviation 7.4

SECONDARY outcome

Timeframe: During initial hospital stay, expected <= 120 days

Duration of supplemental oxygen, and hospital stay

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Duration of Supplemental Oxygen, Intensive Care, Hospital Stay
Duration of supplemental oxygen (days)
7.4 number of days
Standard Deviation 18.5
9.0 number of days
Standard Deviation 22.9
10.7 number of days
Standard Deviation 25.2
8.9 number of days
Standard Deviation 29.3
Duration of Supplemental Oxygen, Intensive Care, Hospital Stay
Length of hospital stay (days)
29.9 number of days
Standard Deviation 28
26.4 number of days
Standard Deviation 24.3
32.1 number of days
Standard Deviation 29.9
28.3 number of days
Standard Deviation 30.8

SECONDARY outcome

Timeframe: During initial hospital stay, expected 1st 2 weeks of life

Age at start of feeds, and age at full enteral feeds presented in days

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=36 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=34 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Age at Start of Feeds, Feeding Progression, Age at Full Enteral Feeds
Age at start of feeds (days)
1.3 age in days
Standard Deviation .7
1.6 age in days
Standard Deviation 1.7
1.8 age in days
Standard Deviation 1.7
1.5 age in days
Standard Deviation 1.1
Age at Start of Feeds, Feeding Progression, Age at Full Enteral Feeds
Age at full enteral feeds (days)
11.2 age in days
Standard Deviation 8.8
7.8 age in days
Standard Deviation 7.3
11.8 age in days
Standard Deviation 11.7
12.9 age in days
Standard Deviation 12.9

SECONDARY outcome

Timeframe: During initial hospital stay, expected <= 120 days

Number of infants requiring blood transfusions

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Need for Blood Transfusions
10 Participants
6 Participants
8 Participants
7 Participants

SECONDARY outcome

Timeframe: At 7 days, 28 days, 36 weeks corrected GA and discharge

Weight at discharge

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Growth Parameters
2153 grams
Standard Deviation 458
2222 grams
Standard Deviation 431
2235 grams
Standard Deviation 561
2281 grams
Standard Deviation 522

SECONDARY outcome

Timeframe: During initial hospital stay, expected <= 120 days

Grade III \& IV IVH PDA requiring ligation ROP treated with Laser Surgical NEC BPD

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Morbidities Associated With Prematurity
Grade III & IV IVH
0 Participants
1 Participants
0 Participants
1 Participants
Morbidities Associated With Prematurity
PDA requiring ligation
0 Participants
1 Participants
0 Participants
0 Participants
Morbidities Associated With Prematurity
ROP treated with Laser
0 Participants
1 Participants
0 Participants
1 Participants
Morbidities Associated With Prematurity
Surgical NEC
0 Participants
0 Participants
2 Participants
2 Participants
Morbidities Associated With Prematurity
BPD
4 Participants
4 Participants
5 Participants
2 Participants

SECONDARY outcome

Timeframe: During initial hospital stay, expected <= 120 days

Survival to hospital discharge

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Survival to Hospital Discharge
37 Participants
38 Participants
35 Participants
39 Participants

SECONDARY outcome

Timeframe: During initial hospital stay, expected <= 120 days

Survival to discharge without severe BPD, severe IVH, surgical NEC or ROP treated with Laser

Outcome measures

Outcome measures
Measure
Dose Schedule I
n=37 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 Participants
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 Participants
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Survival to Discharge Without Severe Morbidity
37 Participants
35 Participants
33 Participants
35 Participants

Adverse Events

Dose Schedule I

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Dose Schedule II

Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths

Dose Schedule III

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Dose Schedule IV

Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Dose Schedule I
n=37 participants at risk
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule II
n=38 participants at risk
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule III
n=35 participants at risk
Surfactant dose to be administered as aerosol - 100 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Dose Schedule IV
n=39 participants at risk
Surfactant dose to be administered as aerosol - 200 mg phospholipid/kg. Surfactant: Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
Respiratory, thoracic and mediastinal disorders
Surfactant reflux from nose/mouth
8.1%
3/37 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
21.1%
8/38 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
11.4%
4/35 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
30.8%
12/39 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
Respiratory, thoracic and mediastinal disorders
Desaturations
5.4%
2/37 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
7.9%
3/38 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
11.4%
4/35 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
17.9%
7/39 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
Respiratory, thoracic and mediastinal disorders
Plugging of nasal prongs
2.7%
1/37 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
2.6%
1/38 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
2.9%
1/35 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
5.1%
2/39 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
Respiratory, thoracic and mediastinal disorders
Increased secretions requiring suctioning
2.7%
1/37 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
18.4%
7/38 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
5.7%
2/35 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
0.00%
0/39 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
Respiratory, thoracic and mediastinal disorders
Residual surfactant in nasal prongs
0.00%
0/37 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
0.00%
0/38 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
2.9%
1/35 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
5.1%
2/39 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
Respiratory, thoracic and mediastinal disorders
Dislodged prongs
2.7%
1/37 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
2.6%
1/38 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
5.7%
2/35 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours
5.1%
2/39 • During and within 6 hours after the end of study drug administration, an expected maximum of approximately 14 hours

Additional Information

Beena G. Sood, MD, MS

Wayne State University

Phone: 313-745-5638

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place