Status:
ACTIVE_NOT_RECRUITING
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Intestinal Perforation
Eligibility:
All Genders
Brief 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...
Eligibility Criteria
Inclusion
- Infants who:
- were admitted to a neonatal unit between the 1st January 2016 and 31st March 2023 and
- received any of their care in a NHS neonatal unit in England and Wales (part of UK Neonatal Collaborative and therefore contributing data to the NNRD) and
- were born before 28 weeks' gestation.
Exclusion
- They have missing data for principal background variables (gestational age at birth, birth weight, year of birth and date of death for those that died).
- Their recorded birthweight absolute value z score exceeds 4 or is missing.
- They died on postnatal day 1 or 2 .
Key Trial Info
Start Date :
July 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
16000 Patients enrolled
Trial Details
Trial ID
NCT06515405
Start Date
July 30 2024
End Date
August 30 2025
Last Update
October 3 2024
Active Locations (1)
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1
Imperial College
London, United Kingdom, SW10 9NH