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Hydrocortisone to Treat Early Bronchopulmonary Dysplasia in Very Preterm Infants: Study Protocol for a Randomized Controlled Trial

Hydrocortisone to Treat Early Bronchopulmonary Dysplasia in Very Preterm Infants: Study Protocol for a Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021854
Enrollment
Unknown
Registered
2019-03-13
Start date
2019-08-01
Completion date
Unknown
Last updated
2020-04-06

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

Conditions

Bronchopulmonary Dysplasia

Interventions

Group 1:Hydrocortisone
Group 2:receive the equal volume saline

Sponsors

Southwest Medical University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1) Gestational age 26+0 to 30+6 weeks and birth weight 0.3 or .non-invasive ventilation support or nasal cannula with FiO2 > 0.21.

Exclusion criteria

Exclusion criteria: Exclusion criteria including any of the following conditions: 1) Need of invasive ventilation support at 28th day of life. 2) Congenital malformations affecting pulmonary function (e.g. congenital surfactant protein deficiencies, congenital diaphragmatic hernia) or increasing the risk of death or adverse neurodevelopmental outcome (e.g. congenital cerebral malformations, congenital hydrocephalus). 3) Chromosomal defects (e.g. trisomy 13, 18, 21). 4) Severe infection less than 7 days before randomization (Late-onset sepsis/ meningitis confirmed by positive blood culture; bacterial pneumonia, confirmed by positive tracheal culture; NEC).

Design outcomes

Primary

MeasureTime frame
The primary outcome is to assess survival without moderate or severe BPD at PMA 36 weeks.;

Countries

China

Contacts

Public ContactXiaoping Lei

Southwest Medical University Affiliated Hospital

leixiaopingde@126.com+86 13550883959

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 26, 2026