Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants
- Registration Number
- NCT06515405
- Lead Sponsor
- Imperial College London
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 16000
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.
- 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 .
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Not exposed to early hydrocortisone Hydrocortisone - Exposed to early hydrocortisone Hydrocortisone -
- Primary Outcome Measures
Name Time Method Gastrointestinal (GI) perforation From date of birth until day 14 of life A baby will be considered to have had a gastrointestinal perforation if their National Neonatal Research Database record includes a record of a GI perforation in the diagnoses field.
- Secondary Outcome Measures
Name Time Method Survival without gastrointestinal perforation From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months Baby survived to discharge from neonatal unit without a gastrointestinal perforation
Total length of stay From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months Length of stay in neonatal care
Proportion of days on unit being mechanically ventilated From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months Bronchopulmonary dysplasia From date of birth until 36 weeks' postmenstrual age (PMA) Using an adapted Jensen criteria based on the highest level of respiratory support at 36 weeks PMA
Mortality before discharge home From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months Baby died before discharge from neonatal unit
Trial Locations
- Locations (1)
Imperial College
🇬🇧London, United Kingdom