Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants

Active, not recruitingOBSERVATIONAL
Enrollment

16,000

Participants

Timeline

Start Date

July 30, 2024

Primary Completion Date

December 30, 2024

Study Completion Date

August 30, 2025

Conditions
Intestinal Perforation
Interventions
DRUG

Hydrocortisone

"Cohort members will be considered to be exposed to early hydrocortisone if either:~1. They receive early hydrocortisone started on postnatal day 1 or 2 and given for more than seven consecutive days OR~2. They receive early hydrocortisone started on postnatal day 1 or 2 and are being cared for in a PROHYDRO unit but die on or before postnatal day 8.~PROHYDRO units are defined as units who, at the time the baby was born, had implemented a protocol for use of prophylactic hydrocortisone as part of routine care for babies born less than 28 weeks' gestation. A unit may change from being a non-PROHYDRO unit to a PROHYDRO unit if a new early hydrocortisone protocol is introduced during the study period (2016-2023)."

Trial Locations (1)

SW10 9NH

Imperial College, London

All Listed Sponsors
collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

lead

Imperial College London

OTHER