NCT06515405

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

Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants: A Protocol for a Retrospective Cohort Study Using Routinely Collected Data

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 16,000 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A large, randomised control trial, the PREMILOC trial, has established that giving low dose hydrocortisone prophylactically in the first ten days of life reduces the risk of bronchopulmonary dysplasia in babies born before 32 weeks' gestation. However, the PREMILOC trial was underpowered to investigate rarer side effects, such as gastrointestinal perforation. This study aims to establish whether the odds of gastrointestinal perforation increase when extremely preterm infants are given prophylactic hydrocortisone in the first ten days of life. This retrospective cohort study will use routinely collected data from the U.K. National Neonatal Research Database. The investigators will examine the records of all infants born before 28 weeks' gestation and cared for in English and Welsh neonatal units between 2016 and 2023. Infants will be considered exposed if they received hydrocortisone for at least eight consecutive days, beginning on postnatal day 1 or 2. The primary outcome will be gastrointestinal perforation, as recorded in the infant's neonatal unit record. This outcome will be validated with the original care teams for a sample of babies. Data will be analysed using a propensity score matched approach to reduce the impact of confounding.

Conditions

• Intestinal Perforation

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2024-07-30
• Primary completion: 2024-12-30
• Completion: 2025-08-30
• First posted: 2024-07-23
• Last updated: 2024-10-03

Locations

1 site across 1 country: United Kingdom