Trial Outcomes & Findings for The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age (NCT NCT02636868)
NCT ID: NCT02636868
Last Updated: 2021-04-23
Results Overview
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
221 participants
Primary outcome timeframe
72 hours
Results posted on
2021-04-23
Participant Flow
Participant milestones
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
76
|
72
|
|
Overall Study
COMPLETED
|
73
|
75
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
2
|
Baseline Characteristics
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
Baseline characteristics by cohort
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=73 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=76 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=72 Participants
nCPAP alone
nCPAP: Nasal CPAP
|
Total
n=221 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Gestational Age
|
30.8 weeks post menstrual age
STANDARD_DEVIATION 1.24 • n=99 Participants
|
30.7 weeks post menstrual age
STANDARD_DEVIATION 1.17 • n=107 Participants
|
30.7 weeks post menstrual age
STANDARD_DEVIATION 1.17 • n=206 Participants
|
30.7 weeks post menstrual age
STANDARD_DEVIATION 1.19 • n=7 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
107 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
114 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
61 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
54 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
160 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
184 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
|
Region of Enrollment
Colombia
|
4 participants
n=99 Participants
|
7 participants
n=107 Participants
|
5 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
5 participants
n=7 Participants
|
|
Region of Enrollment
Hungary
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
18 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=99 Participants
|
25 participants
n=107 Participants
|
21 participants
n=206 Participants
|
66 participants
n=7 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
Poland
|
23 participants
n=99 Participants
|
21 participants
n=107 Participants
|
21 participants
n=206 Participants
|
65 participants
n=7 Participants
|
|
Region of Enrollment
Chile
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
11 participants
n=206 Participants
|
39 participants
n=7 Participants
|
|
Birth Weight
|
1557.0 grams
STANDARD_DEVIATION 342.38 • n=99 Participants
|
1505.8 grams
STANDARD_DEVIATION 378.5 • n=107 Participants
|
1446.4 grams
STANDARD_DEVIATION 359.13 • n=206 Participants
|
1503.4 grams
STANDARD_DEVIATION 361.73 • n=7 Participants
|
|
Ruptured Membranes
Spontaneous
|
23 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Ruptured Membranes
Artificial
|
50 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
163 Participants
n=7 Participants
|
|
Chorioamnionitis
Yes
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Chorioamnionitis
No
|
70 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
213 Participants
n=7 Participants
|
|
Steroid Use, Maternal
Used Steroids
|
68 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
207 Participants
n=7 Participants
|
|
Steroid Use, Maternal
No Steroids
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Mode of Delivery
Vaginal
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
45 Participants
n=7 Participants
|
|
Mode of Delivery
Cesarean Section
|
56 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
176 Participants
n=7 Participants
|
|
Birth Status
Single Birth
|
44 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
147 Participants
n=7 Participants
|
|
Birth Status
Multiple Birth
|
29 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
|
Appearance, Pulse, Grimace, Activity, and Respiration (Apgar) Score at One Minute
|
6.7 Scores on a scale
STANDARD_DEVIATION 1.74 • n=99 Participants
|
6.5 Scores on a scale
STANDARD_DEVIATION 1.71 • n=107 Participants
|
6.8 Scores on a scale
STANDARD_DEVIATION 1.61 • n=206 Participants
|
6.6 Scores on a scale
STANDARD_DEVIATION 1.69 • n=7 Participants
|
|
Apgar Score at Five Minutes
|
8.1 Scores on a scale
STANDARD_DEVIATION 0.90 • n=99 Participants
|
8.0 Scores on a scale
STANDARD_DEVIATION 1.02 • n=107 Participants
|
8.1 Scores on a scale
STANDARD_DEVIATION 1.00 • n=206 Participants
|
8.1 Scores on a scale
STANDARD_DEVIATION 0.97 • n=7 Participants
|
|
Congenital Anomaly
Yes
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Congenital Anomaly
No
|
72 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
220 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 72 hoursPopulation: Modified Intent-to-Treat; randomized subjects who received study treatment
Number of participants who had respiratory failure due to RDS or death due to RDS; known as nasal continuous positive airway pressure (nCPAP) failure
Outcome measures
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=70 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=72 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 Participants
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Number of Participants With Respiratory Failure or Death Due to Respiratory Distress Syndrome (RDS)
|
31 Participants
|
32 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Modified Intent-to-Treat Population without Treatment Interruptions
Incidence of Respiratory Failure or Death Due to RDS by Intubation or Failure Criteria
Outcome measures
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=64 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=44 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 Participants
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Incidence of Respiratory Failure or Death Due to RDS
|
28 Participants
|
14 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Modified Intent-to-Treat; randomized participants who received study treatment
Time from birth to nCPAP Failure
Outcome measures
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=70 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=72 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 Participants
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Time to nCPAP Failure
|
39.3 hours
Standard Error 2.06
|
44.8 hours
Standard Error 2.69
|
40.7 hours
Standard Error 2.44
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: Modified Intent-to-Treat
The measure tests the differences between treatments on respiratory failure or death due to RDS using Poisson distribution modeling, which accounts for the time over which the event could have occurred.
Outcome measures
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=70 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=72 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 Participants
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Incidence of Respiratory Failure or Death Due to RDS With Poisson Distribution Modeling
|
31 Participants
|
32 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Modified Intent-to-Treat
Incidence of Respiratory Failure or Death due to RDS by Intubation or Failure Criteria
Outcome measures
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=70 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=72 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 Participants
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Incidence of Respiratory Failure or Death Due to RDS
|
35 Participants
|
32 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: 36 weeks post-menstrual age (PMA)Population: Modified Intent-to-Treat
Summarizes the number of participants with BPD or alive without BPD
Outcome measures
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=70 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=72 Participants
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 Participants
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
BPD
|
7 Participants
|
7 Participants
|
10 Participants
|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Alive without BPD
|
62 Participants
|
64 Participants
|
59 Participants
|
Adverse Events
Aerosolized Lucinactant (40 mg TPL/kg)
Serious events: 16 serious events
Other events: 65 other events
Deaths: 0 deaths
Aerosolized Lucinactant (80 mg TPL/kg)
Serious events: 14 serious events
Other events: 69 other events
Deaths: 1 deaths
nCPAP Only
Serious events: 20 serious events
Other events: 66 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=70 participants at risk
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=72 participants at risk
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 participants at risk
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Cardiac disorders
Patent ductus arteriosus
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/72 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/71 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Bacteraemia
|
2.9%
2/70 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/71 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Meningitis bacterial
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Neurological infection
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Nocosomial infection
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Sepsis neonatal
|
2.9%
2/70 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/72 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
7.0%
5/71 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Septic embolus
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Septic shock
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Nervous system disorders
Hydrocephalus
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Intraventricular haemorrhage neonatal
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Necrotising enterocolitis neonatal
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal respiratory distress syndrome
|
5.7%
4/70 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/72 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.3%
3/70 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
9.9%
7/71 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/71 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema neonatal
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
0.00%
0/72 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
Other adverse events
| Measure |
Aerosolized Lucinactant (40 mg TPL/kg)
n=70 participants at risk
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
Aerosolized Lucinactant (80 mg TPL/kg)
n=72 participants at risk
Lucinactant for inhalation with nCPAP; up to 2 repeat doses will be allowed if repeat dosing criteria are met.
Lucinactant delivered via investigational delivery device: Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
nCPAP: Nasal CPAP
|
nCPAP Only
n=71 participants at risk
nCPAP alone
nCPAP: Nasal CPAP
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
31.4%
22/70 • Number of events 26 • Enrollment to 36 weeks post-menstrual age
|
43.1%
31/72 • Number of events 37 • Enrollment to 36 weeks post-menstrual age
|
43.7%
31/71 • Number of events 52 • Enrollment to 36 weeks post-menstrual age
|
|
Blood and lymphatic system disorders
Coagulation disorder neonatal
|
2.9%
2/70 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
6.9%
5/72 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
4/70 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
8.3%
6/72 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
7.0%
5/71 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
|
Cardiac disorders
Patent ductus arteriosus
|
25.7%
18/70 • Number of events 18 • Enrollment to 36 weeks post-menstrual age
|
33.3%
24/72 • Number of events 24 • Enrollment to 36 weeks post-menstrual age
|
33.8%
24/71 • Number of events 26 • Enrollment to 36 weeks post-menstrual age
|
|
Cardiac disorders
Tachycardia
|
8.6%
6/70 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
8.3%
6/72 • Number of events 9 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/71 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
5.7%
4/70 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/71 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Abdominal distension
|
8.6%
6/70 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
6.9%
5/72 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
8.5%
6/71 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Constipation
|
8.6%
6/70 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
12.5%
9/72 • Number of events 9 • Enrollment to 36 weeks post-menstrual age
|
8.5%
6/71 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
4.3%
3/70 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/72 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
8.5%
6/71 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
1.4%
1/70 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/71 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Regurgitation
|
14.3%
10/70 • Number of events 10 • Enrollment to 36 weeks post-menstrual age
|
16.7%
12/72 • Number of events 13 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
9/70 • Number of events 9 • Enrollment to 36 weeks post-menstrual age
|
12.5%
9/72 • Number of events 10 • Enrollment to 36 weeks post-menstrual age
|
11.3%
8/71 • Number of events 9 • Enrollment to 36 weeks post-menstrual age
|
|
General disorders
Oedema
|
10.0%
7/70 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
6.9%
5/72 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
9.9%
7/71 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Conjunctivitis
|
5.7%
4/70 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/72 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Pneumonia
|
5.7%
4/70 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Infections and infestations
Sepsis neonatal
|
2.9%
2/70 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/72 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
11.3%
8/71 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
|
Investigations
Cardiac murmur
|
7.1%
5/70 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Investigations
Oxygen saturation decreased
|
31.4%
22/70 • Number of events 31 • Enrollment to 36 weeks post-menstrual age
|
34.7%
25/72 • Number of events 35 • Enrollment to 36 weeks post-menstrual age
|
21.1%
15/71 • Number of events 22 • Enrollment to 36 weeks post-menstrual age
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
15.7%
11/70 • Number of events 11 • Enrollment to 36 weeks post-menstrual age
|
23.6%
17/72 • Number of events 17 • Enrollment to 36 weeks post-menstrual age
|
14.1%
10/71 • Number of events 11 • Enrollment to 36 weeks post-menstrual age
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
2/70 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
6.9%
5/72 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
4.3%
3/70 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/71 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.3%
3/70 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
9.7%
7/72 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.7%
4/70 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/72 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
5/70 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
8.3%
6/72 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
7.0%
5/71 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
5.7%
4/70 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
6.9%
5/72 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
12.7%
9/71 • Number of events 11 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Agitation neonatal
|
10.0%
7/70 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
12.5%
9/72 • Number of events 10 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Bradycardia neonatal
|
8.6%
6/70 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
11.1%
8/72 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Intraventricular haemorrhage neonatal
|
10.0%
7/70 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
13.9%
10/72 • Number of events 11 • Enrollment to 36 weeks post-menstrual age
|
16.9%
12/71 • Number of events 15 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
58.6%
41/70 • Number of events 47 • Enrollment to 36 weeks post-menstrual age
|
68.1%
49/72 • Number of events 50 • Enrollment to 36 weeks post-menstrual age
|
57.7%
41/71 • Number of events 46 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Neonatal respiratory distress syndrome
|
14.3%
10/70 • Number of events 12 • Enrollment to 36 weeks post-menstrual age
|
11.1%
8/72 • Number of events 8 • Enrollment to 36 weeks post-menstrual age
|
18.3%
13/71 • Number of events 13 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Retinopathy of prematurity
|
4.3%
3/70 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
8.3%
6/72 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
|
Pregnancy, puerperium and perinatal conditions
Weight decrease neonatal
|
2.9%
2/70 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/71 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea neonatal
|
44.3%
31/70 • Number of events 39 • Enrollment to 36 weeks post-menstrual age
|
36.1%
26/72 • Number of events 29 • Enrollment to 36 weeks post-menstrual age
|
38.0%
27/71 • Number of events 31 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis neonatal
|
0.00%
0/70 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/71 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonaria dysplasia
|
8.6%
6/70 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
8.3%
6/72 • Number of events 6 • Enrollment to 36 weeks post-menstrual age
|
12.7%
9/71 • Number of events 9 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
4.3%
3/70 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
1.4%
1/71 • Number of events 1 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
10.0%
7/70 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
13.9%
10/72 • Number of events 10 • Enrollment to 36 weeks post-menstrual age
|
9.9%
7/71 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal tachypnoea
|
17.1%
12/70 • Number of events 14 • Enrollment to 36 weeks post-menstrual age
|
13.9%
10/72 • Number of events 11 • Enrollment to 36 weeks post-menstrual age
|
11.3%
8/71 • Number of events 9 • Enrollment to 36 weeks post-menstrual age
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.7%
4/70 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/72 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/71 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
10.0%
7/70 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
8.3%
6/72 • Number of events 7 • Enrollment to 36 weeks post-menstrual age
|
2.8%
2/71 • Number of events 2 • Enrollment to 36 weeks post-menstrual age
|
|
Vascular disorders
Hypotension
|
2.9%
2/70 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 4 • Enrollment to 36 weeks post-menstrual age
|
|
Vascular disorders
Pallor
|
14.3%
10/70 • Number of events 11 • Enrollment to 36 weeks post-menstrual age
|
5.6%
4/72 • Number of events 5 • Enrollment to 36 weeks post-menstrual age
|
4.2%
3/71 • Number of events 3 • Enrollment to 36 weeks post-menstrual age
|
Additional Information
Executive Director of Biostatistics & Data Management
Windtree Therapeutics, Inc.
Phone: 215-488-9477
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Steering Committee is responsible for publications, including who will be authoring publications. The sponsor has the right to review publications before they are published and can provide suggested edits, but cannot require changes or prevent publication.
- Publication restrictions are in place
Restriction type: OTHER