Trial Search Results

Hydrocortisone for BPD

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

NICHD Neonatal Research Network

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Stanford Investigator(s):

Intervention(s):

  • Drug: Hydrocortisone
  • Drug: Placebo

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

N/A - 30 Weeks

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Krisa P. Van Meurs, MD
650-723-5711
Not Recruiting