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

Study ID
STU 062011-045

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Diana Vasil
214-648-3789
diana.vasil@utsouthwestern.edu

Principal Investigator
Myra Wyckoff

Summary

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.

This will be a prospective secondary study involving a subset of infants enrolled in the
niCHD nRn [Quote]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 [Less Than] 30 weeks gestational age[Quote]. : a single echocardiogram will be performed at 36 weeks PMa or after at least 34 weeks if discharged/transferred between 34 and 36 weeks. Length weight
will be obtained from the patient records for calculation of body surface area using Mosteller formula38, where BSa (m([SQuaReD]) [?] ([Height(cm) x Weight(kg) ]/ 3600 )[1/2]), which will be used to calculate the left ventricular mass index. Blood pressure will be recorded from patient's chart at the time of heart echocardiogram. Respiratory support at 36 weeks
PMa will be collected to categorize the patients into mild, moderate and severe BPD.

Participant Eligibility

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