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A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia (BPD) and on Neurodevelopmental Outcomes at 22-26 Months of Age in Intubated Infants <30 Weeks Gestational Age

Study Type/Phase: Interventional
Status: Not Recruiting

This study examines bronchopulmonary dysplasia (BPD), a chronic lung disease of children who were born early and required mechanical ventilation (breathing machine). Children with BPD may need extra oxygen or other breathing support for a long time and have a higher risk of growth and development problems. Medicines called glucocorticoids (or steroids) can decrease lung inflammation and may decrease BPD, but artificial steroids, the medication currently used for BPD, also have adverse effects in infants. Hydrocortisone is identical to the body’s own glucocorticoid (cortisol), which reduces inflammation in the body.

The purpose of this research study is to find out whether giving hydrocortisone to babies who are on a breathing machine can help get them off this respiratory support and lower their risk of developing BPD. Each patient will be randomly assigned to either receive hydrocortisone or a placebo (salt water) over a 10 day period. This study will continue to collect information about the infant’s heath until he/she is 22-26 months, corrected for prematurity.

Up to 30 children will be enrolled at El Camino Hospital and Stanford.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion 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
  • 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

Principal Investigator

Krisa Van Meurs, MD and Ritu Chitkara, MD

Sponsor

NICHD Neonatal Research Network

NCT Number

NCT01353313

Contact

Krisa Van Meurs, MD and Ritu Chitkara, MD
vanmeurs@stanford.edu
chitkara@stanford.edu

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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