An observational study in Intestinal Perforation, sponsored by Imperial College London. Active, not recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Imperial College London · Observational
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.
36 studies on the registry are indexed under Intestinal Perforation; 5 are open to participants now.
This study's planned enrollment of 16,000 is above the median of 203 across 20 observational studies indexed under Intestinal Perforation.
Browse Intestinal Perforation studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infants born before 28 weeks' gestation and admitted to English and Welsh neonatal units.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Infants who:
Exclusion Criteria:
Drug: Hydrocortisone
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).
Gastrointestinal (GI) perforation
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.
Time frame: From date of birth until day 14 of life
Survival without gastrointestinal perforation
Baby survived to discharge from neonatal unit without a gastrointestinal perforation
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Mortality before discharge home
Baby died before discharge from neonatal unit
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Total length of stay
Length of stay in neonatal care
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Proportion of days on unit being mechanically ventilated
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Bronchopulmonary dysplasia
any respiratory or ventilatory support or supplemental oxygen at 36 weeks' postmenstrual age (PMA)
Time frame: From date of birth until 36 weeks' postmenstrual age (PMA)
Bronchopulmonary dysplasia
Using an adapted Jensen criteria based on the highest level of respiratory support at 36 weeks PMA
Time frame: From date of birth until 36 weeks' postmenstrual age (PMA)
Necrotising enterocolitis
UK National Neonatal Audit Programme definition
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Severe necrotising enterocolitis
Necrotising enterocolitis confirmed at surgery or post-mortem or stated as cause of death
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Pragmatically defined necrotising enterocolitis
a recorded diagnosis of necrotising enterocolitis and received at least 5 consecutive days of antibiotics whilst also nil by mouth
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Late onset sepsis
One or more episodes of a positive blood or cerebrospinal fluid culture with either a pure or mixed growth of a known pathogenic organism after the first three days following birth
Time frame: From postnatal day 3 until the date of discharge from final neonatal unit, assessed up to 24 months
Brain injury occurring at or soon after birth
Intracranial haemorrhage, perinatal stroke, central nervous system infection, kernicterus (bilirubin encephalopathy), periventricular leukomalacia or any recorded seizure
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
Treated retinopathy of prematurity
Cryotherapy, laser therapy or injection of anti-vascular endothelial growth factor therapy for ROP in either or both eyes
Time frame: From date of birth until the date of discharge from final neonatal unit, assessed up to 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Study protocol available now. Analysis code will be available after publication of results.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2024, 5 months after the start.
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This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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