Hydrocortisone for BPD

• Status: Active, not recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Research Resources (NCRR); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Benzyl Alcohol; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

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