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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Page 1 of 1 (1 locations)

1

Imperial College

London, United Kingdom, SW10 9NH

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