Trial Outcomes & Findings for Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants (NCT NCT04184648)
NCT ID: NCT04184648
Last Updated: 2026-04-21
Results Overview
Respiratory adverse outcomes include all types of neonatal lung diseases
Recruitment status
COMPLETED
Target enrollment
322 participants
Primary outcome timeframe
up to 18 months after birth
Results posted on
2026-04-21
Participant Flow
Infants with severe congenital malformations or missing key study data were excluded
Participant milestones
| Measure |
No BPD(2018)
Breathing in room air at 36 weeks PMA
|
BPD at 36 Weeks(2018)
Need for extra oxygen with any form of ventilatory support at 36 weeks PMA
|
|---|---|---|
|
Overall Study
STARTED
|
130
|
140
|
|
Overall Study
COMPLETED
|
130
|
140
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Classification Standards of Bronchopulmonary Dysplasia (BPD) in Premature Infants
Baseline characteristics by cohort
| Measure |
No BPD
n=130 Participants
Breathing in room air at 36 weeks PMA
|
BPD in 2018 Definition
n=140 Participants
Need for oxygen with any form of ventilatory support at 36 weeks PMA
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Gestational age
|
28.8 weeks
STANDARD_DEVIATION 2 • n=13 Participants
|
30.2 weeks
STANDARD_DEVIATION 1.1 • n=13 Participants
|
29.7 weeks
STANDARD_DEVIATION 1.4 • n=26 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=13 Participants
|
56 Participants
n=13 Participants
|
114 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=13 Participants
|
84 Participants
n=13 Participants
|
156 Participants
n=26 Participants
|
|
Race/Ethnicity, Customized
Chinese Han populations
|
130 Participants
n=13 Participants
|
140 Participants
n=13 Participants
|
270 Participants
n=26 Participants
|
|
Birth weight
|
1398.6 grams
STANDARD_DEVIATION 287 • n=13 Participants
|
1459.5 grams
STANDARD_DEVIATION 277 • n=13 Participants
|
1411.3 grams
STANDARD_DEVIATION 285.3 • n=26 Participants
|
|
Cesarean section
|
65 Participants
n=13 Participants
|
73 Participants
n=13 Participants
|
138 Participants
n=26 Participants
|
|
Prenatal glucocorticosteroids administration
|
74 Participants
n=13 Participants
|
88 Participants
n=13 Participants
|
162 Participants
n=26 Participants
|
PRIMARY outcome
Timeframe: up to 18 months after birthPopulation: Total number of infants with complete follow-up
Respiratory adverse outcomes include all types of neonatal lung diseases
Outcome measures
| Measure |
No BPD
n=130 Participants
Breathing in room air at 36 weeks PMA
|
BPD in 2018 Definition
n=140 Participants
Need for oxygen with any form of ventilatory support at 36 weeks PMA
|
|---|---|---|
|
Respiratory Adverse Outcomes
|
27 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: up to PMA 18-24 monthsheight, weight or head circumference \<3rd percentile for corrected gestational age and sex, growth percentiles defined using the World Health Organization Child Growth Standards
Outcome measures
| Measure |
No BPD
n=130 Participants
Breathing in room air at 36 weeks PMA
|
BPD in 2018 Definition
n=140 Participants
Need for oxygen with any form of ventilatory support at 36 weeks PMA
|
|---|---|---|
|
Growth Restriction
|
10 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: up to 18 months after birthdays during which the infants were given oxygen supplement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 18 months after birthincluding length, weight, head circumference
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 18 months after birthsevere neurological outcomes defined as brain retardation assessed by the Child Neurological Development Scale, developmental quotient (DQ) score \<85 assessed by the Gsell developmental schedules of infants, or brain damage requiring rehabilitation treatment assessed by a qualified physical therapist;
Outcome measures
| Measure |
No BPD
n=130 Participants
Breathing in room air at 36 weeks PMA
|
BPD in 2018 Definition
n=140 Participants
Need for oxygen with any form of ventilatory support at 36 weeks PMA
|
|---|---|---|
|
Follow-up of Neurological Development
|
3 Participants
|
11 Participants
|
POST_HOC outcome
Timeframe: up to 18 months after birthChanges in assisted ventilation
Outcome measures
Outcome data not reported
Adverse Events
Neurological Disease in High Risk Infants(+)in NO BPD
Serious events: 5 serious events
Other events: 3 other events
Deaths: 5 deaths
Neurological Disease in High Risk Infants(+)in 2018 BPD
Serious events: 11 serious events
Other events: 7 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Neurological Disease in High Risk Infants(+)in NO BPD
n=130 participants at risk
No BPD but brain retardation assessed by the Child Neurological Development Scale, developmental quotient (DQ) score \<85 assessed by the Gsell developmental schedules of infants, or brain damage requiring rehabilitation treatment assessed by a qualified physical therapist
|
Neurological Disease in High Risk Infants(+)in 2018 BPD
n=140 participants at risk
In BPD group and brain retardation assessed by the Child Neurological Development Scale, developmental quotient (DQ) score \<85 assessed by the Gsell developmental schedules of infants, or brain damage requiring rehabilitation treatment assessed by a qualified physical therapist
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
3.8%
5/130 • Number of events 5 • The follow-up time was 18-24 months
|
7.9%
11/140 • Number of events 11 • The follow-up time was 18-24 months
|
Other adverse events
| Measure |
Neurological Disease in High Risk Infants(+)in NO BPD
n=130 participants at risk
No BPD but brain retardation assessed by the Child Neurological Development Scale, developmental quotient (DQ) score \<85 assessed by the Gsell developmental schedules of infants, or brain damage requiring rehabilitation treatment assessed by a qualified physical therapist
|
Neurological Disease in High Risk Infants(+)in 2018 BPD
n=140 participants at risk
In BPD group and brain retardation assessed by the Child Neurological Development Scale, developmental quotient (DQ) score \<85 assessed by the Gsell developmental schedules of infants, or brain damage requiring rehabilitation treatment assessed by a qualified physical therapist
|
|---|---|---|
|
Nervous system disorders
cerebral palsy
|
2.3%
3/130 • Number of events 3 • The follow-up time was 18-24 months
|
5.0%
7/140 • Number of events 7 • The follow-up time was 18-24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place