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Trial Outcomes & Findings for Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial (NCT NCT03340727)

NCT ID: NCT03340727

Last Updated: 2024-07-31

Results Overview

The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

827 participants

Primary outcome timeframe

Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Results posted on

2024-07-31

Participant Flow

Infants were recruited into the study based on eligibility and parental/guardian consent. Baseline characteristics of the mother were collected (with consent) for use in statistical analysis.

Participant milestones

Participant milestones
Measure
Caffeine Citrate
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Overall Study
STARTED
416
411
Overall Study
Completed In-hospital Stay
390
397
Overall Study
COMPLETED
345
351
Overall Study
NOT COMPLETED
71
60

Reasons for withdrawal

Reasons for withdrawal
Measure
Caffeine Citrate
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Overall Study
Death
1
0
Overall Study
Lost to Follow-up
31
35
Overall Study
Still in hospital at 48 0/7 wks Post-menstrual Age (PMA)
1
1
Overall Study
Transferred to another facility
10
7
Overall Study
Withdrawal by Subject
28
17

Baseline Characteristics

Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Caffeine
n=416 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Total
n=827 Participants
Total of all reporting groups
Age, Continuous
30 years
STANDARD_DEVIATION 5.8 • n=99 Participants
29.9 years
STANDARD_DEVIATION 5.8 • n=107 Participants
29.9 years
STANDARD_DEVIATION 5.8 • n=206 Participants
Sex/Gender, Customized
Female
213 Participants
n=99 Participants
207 Participants
n=107 Participants
420 Participants
n=206 Participants
Sex/Gender, Customized
Male
203 Participants
n=99 Participants
204 Participants
n=107 Participants
407 Participants
n=206 Participants
Race/Ethnicity, Customized
American Indian or Alaskan Native
7 Participants
n=99 Participants
12 Participants
n=107 Participants
19 Participants
n=206 Participants
Race/Ethnicity, Customized
Asian
12 Participants
n=99 Participants
9 Participants
n=107 Participants
21 Participants
n=206 Participants
Race/Ethnicity, Customized
Black
110 Participants
n=99 Participants
110 Participants
n=107 Participants
220 Participants
n=206 Participants
Race/Ethnicity, Customized
More Than One Race
3 Participants
n=99 Participants
2 Participants
n=107 Participants
5 Participants
n=206 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
4 Participants
n=99 Participants
4 Participants
n=107 Participants
8 Participants
n=206 Participants
Race/Ethnicity, Customized
Unknown
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Race/Ethnicity, Customized
Unknown or Not Reported
13 Participants
n=99 Participants
10 Participants
n=107 Participants
23 Participants
n=206 Participants
Race/Ethnicity, Customized
White
265 Participants
n=99 Participants
261 Participants
n=107 Participants
526 Participants
n=206 Participants
Race/Ethnicity, Customized
Hispanic or Latino
63 Participants
n=99 Participants
54 Participants
n=107 Participants
117 Participants
n=206 Participants
Race/Ethnicity, Customized
Not Hispanic or Latino
338 Participants
n=99 Participants
345 Participants
n=107 Participants
683 Participants
n=206 Participants
Marital status
Married
213 Participants
n=99 Participants
233 Participants
n=107 Participants
446 Participants
n=206 Participants
Marital status
Single
200 Participants
n=99 Participants
175 Participants
n=107 Participants
375 Participants
n=206 Participants
Marital status
Unknown
3 Participants
n=99 Participants
3 Participants
n=107 Participants
6 Participants
n=206 Participants
Mothers education, Customized
8th grade or less
9 Participants
n=99 Participants
5 Participants
n=107 Participants
14 Participants
n=206 Participants
Mothers education, Customized
9th to 12th grade
33 Participants
n=99 Participants
22 Participants
n=107 Participants
55 Participants
n=206 Participants
Mothers education, Customized
College degree
68 Participants
n=99 Participants
75 Participants
n=107 Participants
143 Participants
n=206 Participants
Mothers education, Customized
Graduate degree
38 Participants
n=99 Participants
38 Participants
n=107 Participants
76 Participants
n=206 Participants
Mothers education, Customized
High School degree
86 Participants
n=99 Participants
102 Participants
n=107 Participants
188 Participants
n=206 Participants
Mothers education, Customized
Partial college/Associate degree
93 Participants
n=99 Participants
90 Participants
n=107 Participants
183 Participants
n=206 Participants
Mothers education, Customized
Trade or technical school
10 Participants
n=99 Participants
10 Participants
n=107 Participants
20 Participants
n=206 Participants
Mothers education, Customized
Unknown
79 Participants
n=99 Participants
69 Participants
n=107 Participants
148 Participants
n=206 Participants
Mothers insurance, Customized
Private
207 Participants
n=99 Participants
213 Participants
n=107 Participants
420 Participants
n=206 Participants
Mothers insurance, Customized
Public
203 Participants
n=99 Participants
190 Participants
n=107 Participants
393 Participants
n=206 Participants
Mothers insurance, Customized
Self-pay/uninsured
6 Participants
n=99 Participants
7 Participants
n=107 Participants
13 Participants
n=206 Participants
Mothers insurance, Customized
Unknown
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Gravidity
2.5 years
n=99 Participants
2 years
n=107 Participants
2 years
n=206 Participants
Parity
2 years
n=99 Participants
2 years
n=107 Participants
2 years
n=206 Participants
Gestational Age
31.2 weeks
STANDARD_DEVIATION 1.2 • n=99 Participants
31.2 weeks
STANDARD_DEVIATION 1.2 • n=107 Participants
31.2 weeks
STANDARD_DEVIATION 1.2 • n=206 Participants
Birth weight of infant
1545 grams
STANDARD_DEVIATION 358.1 • n=99 Participants
1564.3 grams
STANDARD_DEVIATION 357.4 • n=107 Participants
1554.6 grams
STANDARD_DEVIATION 357.7 • n=206 Participants
Apgar score of Infant at 1 minute after birth
6 score
n=99 Participants
6 score
n=107 Participants
6 score
n=206 Participants
Apgar score of Infant at 5 minutes after birth
8 score
n=99 Participants
8 score
n=107 Participants
8 score
n=206 Participants
Number of Infants who Required Oxygen
No
71 Participants
n=99 Participants
68 Participants
n=107 Participants
139 Participants
n=206 Participants
Number of Infants who Required Oxygen
Unknown
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Number of Infants who Required Oxygen
Yes
344 Participants
n=99 Participants
342 Participants
n=107 Participants
686 Participants
n=206 Participants
Number of Infants who Required Positive pressure ventilation
No
188 Participants
n=99 Participants
185 Participants
n=107 Participants
373 Participants
n=206 Participants
Number of Infants who Required Positive pressure ventilation
Unknown
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Number of Infants who Required Positive pressure ventilation
Yes
228 Participants
n=99 Participants
225 Participants
n=107 Participants
453 Participants
n=206 Participants
Number of Infants who Required CPAP
No
81 Participants
n=99 Participants
81 Participants
n=107 Participants
162 Participants
n=206 Participants
Number of Infants who Required CPAP
Unknown
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Number of Infants who Required CPAP
Yes
335 Participants
n=99 Participants
329 Participants
n=107 Participants
664 Participants
n=206 Participants
Number of Infants who Required Intubation
No
370 Participants
n=99 Participants
366 Participants
n=107 Participants
736 Participants
n=206 Participants
Number of Infants who Required Intubation
Yes
46 Participants
n=99 Participants
45 Participants
n=107 Participants
91 Participants
n=206 Participants
Number of Infants who Required Chest compressions
No
416 Participants
n=99 Participants
405 Participants
n=107 Participants
821 Participants
n=206 Participants
Number of Infants who Required Chest compressions
Unknown
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
Number of Infants who Required Chest compressions
Yes
0 Participants
n=99 Participants
5 Participants
n=107 Participants
5 Participants
n=206 Participants
Number of Infants who Required Epinephrine
No
416 Participants
n=99 Participants
409 Participants
n=107 Participants
825 Participants
n=206 Participants
Number of Infants who Required Epinephrine
Yes
0 Participants
n=99 Participants
2 Participants
n=107 Participants
2 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of days between randomization and hospital discharge. This outcome is censored at 48 weeks PMA and at time of transfer or death.

Outcome measures

Outcome measures
Measure
Caffeine
n=415 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=410 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of Days Between Randomization and Hospital Discharge
18 days
Interval 10.0 to 30.0
16.5 days
Interval 10.0 to 27.0

PRIMARY outcome

Timeframe: Discharge through 4 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of sick visits related to apneic or apparent life-threatening events within first 4 weeks post-discharge MEASTYPE=SEC

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 4 Weeks Post-discharge
0 count of apnea visits
Interval 0.0 to 0.0
0 count of apnea visits
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of days to physiologic maturity after randomization. Physiologic maturity is defined: 1. Temperature: out of the incubator for at least 48 hours with normal body temperature; 2. Feeding: oral feeding at a volume of at least 140 ml/kg for 48 hours or growing on less than 140 ml/kg/day for at least 48 hours; 3. Respiratory: apnea-free for at least 5 consecutive days. This outcome is censored at 48 weeks PMA

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=388 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
The Number of Days to Physiologic Maturity After Randomization
13 days
Interval 7.0 to 23.0
14 days
Interval 8.0 to 23.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of days to when out of incubator for 48 hours: when maintained stable temp for 48 hrs. This outcome is censored at 48 weeks PMA

Outcome measures

Outcome measures
Measure
Caffeine
n=201 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=199 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
The Number of Days to When Out of Incubator for 48 Hours: When Maintained Stable Temp for 48 Hrs
5 days
Interval 2.0 to 9.0
5 days
Interval 1.0 to 9.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of days to apnea/ bradycardia free for 5 consecutive days. This outcome is censored at 48 weeks PMA

Outcome measures

Outcome measures
Measure
Caffeine
n=325 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=326 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
The Number of Days to Apnea/ Bradycardia Free for 5 Consecutive Days
8 days
Interval 5.0 to 16.0
11 days
Interval 5.0 to 18.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of days oral feeds \>140 ml/kg/day or growing on less than 140 ml/kg/day for at least 48 hours. This outcome is censored at 48 weeks PMA

Outcome measures

Outcome measures
Measure
Caffeine
n=256 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=251 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
The Number of Days to Oral Feeds >140 ml/kg/Day or Growing on Less Than 140 ml/kg/Day for at Least 48 Hours
14 days
Interval 6.0 to 23.0
12 days
Interval 5.0 to 22.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The post-menstrual age of the infant at discharge censored at 48 weeks PMA and at time of transfer or death

Outcome measures

Outcome measures
Measure
Caffeine
n=415 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Post-menstrual Age at Discharge
37.7 weeks
Interval 37.5 to 37.9
37.6 weeks
Interval 37.4 to 37.8

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Weight gain from randomization until status %(discharge up to 48 wks PMA, with censoring at time of transfer or death%).

Outcome measures

Outcome measures
Measure
Caffeine
n=413 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=410 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Weight Gain From Randomization Until Status
28.9 grams per day
Interval 28.1 to 29.8
32.2 grams per day
Interval 30.9 to 33.4

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of days after randomization until status that infant had at least two consecutive heart rates \>200 documented at least 3 hours apart

Outcome measures

Outcome measures
Measure
Caffeine
n=414 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
The Number of Days After Randomization Until Status That Infant Had at Least Two Consecutive Heart Rates >200 Documented at Least 3 Hours Apart
0 days
Interval 0.0 to 0.0
0 days
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Treatment for high blood pressure initiated after randomization until status.

Outcome measures

Outcome measures
Measure
Caffeine
n=414 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Treatment for High Blood Pressure
No
412 Participants
410 Participants
Treatment for High Blood Pressure
Yes
2 Participants
1 Participants

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of episodes between randomization and status that infant was placed NPO for \>= 24 hours

Outcome measures

Outcome measures
Measure
Caffeine
n=414 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
The Number of Episodes Between Randomization and Status That Infant Was Placed NPO for >= 24 Hours
0 episodes
Interval 0.0 to 0.0
0 episodes
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The use of anti-reflux medications started between randomization and status

Outcome measures

Outcome measures
Measure
Caffeine
n=414 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Use of Anti-reflux Medications
No
384 Participants
387 Participants
Use of Anti-reflux Medications
Yes
30 Participants
24 Participants

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

The number of days that significant apnea/bradycardia, as defined by documentation of infant receiving any of the following between randomization and status: open label caffeine, other methylxanthines, doxapram, CPAP or ventilatory support for apnea/bradycardia.

Outcome measures

Outcome measures
Measure
Caffeine
n=414 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=410 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of Days That Significant Apnea/Bradycardia
0 days
Interval 0.0 to 0.0
0 days
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Randomization through hospital discharge, censored at time of transfer, death, or 48 wks PMA

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

All-cause mortality

Outcome measures

Outcome measures
Measure
Caffeine
n=416 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
All-cause Mortality
No
415 Participants
411 Participants
All-cause Mortality
Yes
1 Participants
0 Participants

SECONDARY outcome

Timeframe: Discharge through 4 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of all-cause readmissions within first 4 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of All-cause Readmissions Within First 4 Weeks Post-discharge
0 count of readmissions
Interval 0.0 to 0.0
0 count of readmissions
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 4 weeks through 8 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of all-cause readmissions within second 4 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of All-cause Readmissions Within Second 4 Weeks Post-discharge
0 count of readmissions
Interval 0.0 to 0.0
0 count of readmissions
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Discharge through 8 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of all-cause readmissions within first 8 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of All-cause Readmissions Within First 8 Weeks Post-discharge
0 count of readmissions
Interval 0.0 to 0.0
0 count of readmissions
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Discharge through 4 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 4 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 4 Weeks Post-discharge
0 count of sick visits
Interval 0.0 to 0.0
0 count of sick visits
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 4 weeks through 8 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within second 4 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within Second 4 Weeks Post-discharge
0 count of sick visits
Interval 0.0 to 0.0
0 count of sick visits
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Discharge through 8 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of all-cause sick visits, urgent care, emergency rooms, or health care provider%'s office, within first 8 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of All-cause Sick Visits, Urgent Care, Emergency Rooms, or Health Care Provider%'s Office, Within First 8 Weeks Post-discharge
0 count of sick visits
Interval 0.0 to 0.0
0 count of sick visits
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 4 weeks through 8 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of sick visits related to apneic or apparent life-threatening events within second 4 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within Second 4 Weeks Post-discharge
0 count of apnea visits
Interval 0.0 to 0.0
0 count of apnea visits
Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: Discharge through 8 weeks post-discharge

Population: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.

Number of sick visits related to apneic or apparent life-threatening events within first 8 weeks post-discharge

Outcome measures

Outcome measures
Measure
Caffeine
n=390 Participants
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=397 Participants
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Number of Sick Visits Related to Apneic or Apparent Life-threatening Events Within First 8 Weeks Post-discharge
0 count of apnea visits
Interval 0.0 to 0.0
0 count of apnea visits
Interval 0.0 to 0.0

Adverse Events

Caffeine

Serious events: 12 serious events
Other events: 10 other events
Deaths: 1 deaths

Placebo

Serious events: 22 serious events
Other events: 24 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Caffeine
n=416 participants at risk
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 participants at risk
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Cardiac disorders
Neonatal tachycardia
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Congenital, familial and genetic disorders
Pyloric stenosis
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.00%
0/411 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Gastrointestinal disorders
Constipation
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.00%
0/411 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Gastrointestinal disorders
Ileal stenosis
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Gastrointestinal disorders
Necrotising enterocolitis neonatal
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.49%
2/411 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Gastrointestinal disorders
Vomiting
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.97%
4/411 • Number of events 4 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Bronchiolitis
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.49%
2/411 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Enterovirus infection
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Influenza
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Mastoiditis
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Meningitis neonatal
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Pneumonia moraxella
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.00%
0/411 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Respiratory syncytial virus infection
0.48%
2/416 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Rhinovirus infection
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.49%
2/411 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Sepsis neonatal
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.49%
2/411 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Subperiosteal abscess
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Upper respiratory tract infection
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Urinary tract infection neonatal
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Injury, poisoning and procedural complications
Road traffic accident
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.00%
0/411 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Metabolism and nutrition disorders
Dehydration
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Metabolism and nutrition disorders
Failure to thrive
0.24%
1/416 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.00%
0/411 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Nervous system disorders
Seizure
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Respiratory, thoracic and mediastinal disorders
Apnea neonatal
0.48%
2/416 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
2.2%
9/411 • Number of events 10 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Respiratory, thoracic and mediastinal disorders
Cyanosis neonatal
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.00%
0/411 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Vascular disorders
Hypertension neonatal
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)

Other adverse events

Other adverse events
Measure
Caffeine
n=416 participants at risk
Daily weight-adjusted doses of Caffeine Citrate while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Placebo
n=411 participants at risk
Daily weight-adjusted doses of Placebo while in the hospital, followed by 4 weeks of at home administration by parent/guardians
Cardiac disorders
Arrhythmia neonatal
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.00%
0/411 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Gastrointestinal disorders
Haematochezia
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.24%
1/411 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Gastrointestinal disorders
Necrotising enterocolitis neonatal
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.49%
2/411 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Infections and infestations
Sepsis neonatal
0.00%
0/416 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
0.49%
2/411 • Number of events 2 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Respiratory, thoracic and mediastinal disorders
Apnea neonatal
0.24%
1/416 • Number of events 1 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
2.2%
9/411 • Number of events 10 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
Vascular disorders
Hypertension neonatal
2.2%
9/416 • Number of events 9 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)
2.4%
10/411 • Number of events 10 • Randomization through 8-weeks post discharge, up to 48 weeks Post-Menstrual Age.
Adverse events were collected on all randomized infants from the time of randomization through the end of the post-discharge follow-up (8 weeks post-discharge or 48 weeks post-menstrual age, whichever comes first)

Additional Information

Abhik Das

RTI International

Phone: 301-770-8214

Results disclosure agreements

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