CompletedPhase 3

Hydrocortisone for BPD

United States800 participantsStarted 2011-08-11

Plain-language summary

The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or placebo. This study will determine if hydrocortisone improves infants'survival without moderate or severe BPD and will be associated with improvement in survival without moderate or severe neurodevelopmental impairment at 22 - 26 months corrected age.

Who can participate

Age range30 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * infants \<30 weeks estimated gestational age * inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age * have received at least 7days of mechanical ventilation; * are receiving mechanical ventilation through an endotracheal tube . Exclusion Criteria: * Major congenital anomalies * Decision to limit support * Indomethacin or ibuprofen treatment within 48 hours of study drug * Previous corticosteroid treatment for BPD * Received hydrocortisone for 14 or more cumulative days * Received hydrocortisone within 7 days of study entry

What they're measuring

Survival Without Moderate/Severe Physiologic Bronchopulmonary Dysplasia (BPD)

Timeframe: From day of randomization to 36 weeks post menstrual age

Survival Without Moderate/Severe Neurodevelopmental Impairment (NDI)

Timeframe: From day of randomization to 22-26 months corrected age

Trial details

NCT IDNCT01353313

SponsorNICHD Neonatal Research Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2020-09-21

Results submitted2022-06-23

View on ClinicalTrials.gov More Infant, Newborn trials