Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515405
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Effect of Early Hydrocortisone on Risk of Gastrointestinal Perforations in Extremely Preterm Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 UK 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 infants 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
This retrospective cohort study will use routinely collected data from the UK 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 infants 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None