A Randomized Controlled Trial of The Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22-26 Months of Age in Intubated Infants <30 Weeks Gestational Age
This will be a multicenter, randomized, controlled clinical trial performed by the NICHD Neonatal research Network (NRN) to study the efficacy and safety of a 10-day tapering course of hydrocortisone treatment for infants [Less Than]30 weeks estimated gestational age at birth who remain intubated at 14 - 28 days postnatal age. The infant will be randomized to saline placebo or hydrocortisone sodium succinate for intravenous administration to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows: 4mg/kg/day / q 6 hours x 2 days, then 2mg/kg/day / q 6 hours x 3 days; then 1mg/kg/day / q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days. The primary outcome for this study will incorporate both (1) survival without moderate to severe BPD by Network physiologic definition and (2) survival without moderate or severe NDI at 22-26 months corrected age. Therefore, the results of this study will be reported only when follow-up data are available unless (1) the trial is stopped early by the DSMC because of strong evidence of benefit or harm, or (2) at the time all subjects have completed treatment, the DSMC finds a substantial survival benefit favoring hydrocortisone (p[Less Than]0.001). Individual study assignment will remain masked until the follow-up is completed. Secondary outcomes will include short term measures such as respiratory morbidities and growth at 36 weeks postmenstrual age and long term measures including growth and other outcomes at 22-26 months corrected age.
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