A clinical trial to study the risk factors of bronchopulmonary dysplasia in Chinese preterm infants

Risk factors for bronchopulmonary dysplasia in preterm infants - a multicenter prospective cohort study in China

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN84167642

Enrollment

1000

Registered

2020-02-25

Start date

2020-03-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary dysplasia in preterm infants Neonatal Diseases Bronchopulmonary dysplasia originating in the perinatal period

Interventions

This study will collect the data from 39 NICU of tertiary hospitals in China, including obstetric conditions, relevant records during delivery, and materials of respiratory support, drug application,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Preterm infants admitted within 72 hours after birth, gestational age <32 weeks and respiratory distress score =5

Exclusion criteria

Exclusion criteria: Congenital malformations such as complex congenital heart disease, diaphragmatic hernia, anomalies of digestive tract/kidney, and genetic metabolic disorders

Design outcomes

Primary

Measure	Time frame
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) 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 The incidence of early death and BPD are calculated by the corresponding rate for the total study population in the database	—

Measure

Time frame

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) 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 The incidence of early death and BPD are calculated by the corresponding rate for the total study population in the database

—

Secondary

Measure	Time frame
The grade and severity of BPD according to the definition of 2018 NICHD BPD workshop at 36 weeks PMA	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026