A clinical trial to study the risk factors of bronchopulmonary dysplasia in Chinese preterm infants
Not Applicable
Completed
- Conditions
- Bronchopulmonary dysplasia in preterm infantsNeonatal DiseasesBronchopulmonary dysplasia originating in the perinatal period
- Registration Number
- ISRCTN84167642
- Lead Sponsor
- Children's Hospital of Zhejiang University
- Brief Summary
2024 Results article in https://doi.org/10.1186/s12887-024-04675-5 (added 04/04/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
Preterm infants admitted within 72 hours after birth, gestational age <32 weeks and respiratory distress score =5
Exclusion Criteria
Congenital malformations such as complex congenital heart disease, diaphragmatic hernia, anomalies of digestive tract/kidney, and genetic metabolic disorders
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Early death (between 14 days of postnatal age and 36 weeks PMA) measured using data from medical records, defined as owing to persistent parenchymal lung disease and respiratory failure that cannot be attributable to other neonatal morbidities (eg, necrotizing enterocolitis, intraventricular hemorrhage, redirection of care, episodes of sepsis, etc)<br>2. BPD at 36 weeks PMA measured using data from medical records, defined as a premature infant (<32 weeks’ gestational age) with persistent parenchymal lung disease confirmed by radiography, and at 36 weeks PMA requires oxygen for =3 consecutive days to maintain arterial oxygen saturation in the 90%–95% range<br><br>The incidence of early death and BPD are calculated by the corresponding rate for the total study population in the database
- Secondary Outcome Measures
Name Time Method The grade and severity of BPD according to the definition of 2018 NICHD BPD workshop at 36 weeks PMA