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. TRaCKinG STuDY (Follow-up) aT 3 and 4 YeaRS Study Design This is a prospective, observational follow-up study at 3 and 4 years corrected age of all surviving children randomized in the nRn HC for BPD trial. We will evaluate the impact of exposure to hydrocortisone and severity of neonatal lung disease on respiratory symptoms and resource utilization. This will also provide an opportunity to update family contact information, which is essential for future early school age follow-up study of the trial population. We seek permission for waiver of documentation of consent and HiPaa authorization, to enable phone consent and questionnaire administration. Verbal permission for the telephone questionnaires will be obtained from families at the time of the telephone calls. Family interest in ongoing follow-up and specifically a 5-year in-person assessment will be assessed during the 3 and 4-year phone calls. exposure(s) and Comparison(s) The primary exposure of interest is hydrocortisone or placebo, as per the original trial randomization. The secondary exposure of interest is severity of BPD. Blinding/Masking Study personnel making the telephone calls will be blinded to HC exposure and severity of BPD The primary outcome of respiratory morbidity is a [Quote]YeS[Quote] answer to one or more of the questions about hospitalizations, emergency room visits, or doctor visits for respiratory symptoms, technology dependence (oxygen, CPaP, or ventilator), and respiratory medication use. if one or more questions is missing and the rest are [Quote]no[Quote], the primary outcome will be categorized as missing. (However, this is expected to occur rarely if at all given the brief nature of the telephone interview.) The components of the primary outcome, wheeze, iCu-level hospitalization, and parent missed work or missed work opportunity due to child's illness will be assessed as secondary outcomes.