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 range

30 Weeks

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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