A study looking at how effective and safe a very low dose of dexamethasone is in helping ventilator-dependent preterm babies who are at high risk of bronchopulmonary dysplasia (a serious lung condition that affects infants) get off the ventilator more quickly and effectively

Phase 2

Completed

• Conditions: Specialty: Children, Primary sub-specialty: Neonatal; UKCRC code/ Disease: Reproductive Health and Childbirth/ Other disorders originating in the perinatal period; Respiratory; Bronchopulmonary dysplasia (BPD)

• Registration Number: ISRCTN81191607
• Lead Sponsor: niversity of Liverpool

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31479218 (added 19/12/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-01
• Study Completion: 2018-11-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Born at <30 weeks’ gestation
2. Aged between 10 and 24 postnatal days (=10 and =24)
3. At high risk of developing BPD: receiving mechanical ventilation via endotracheal tube (ET) with at least 30% inspired oxygen when the positive end expiratory pressure (PEEP) is at least 4 cm water and, in the opinion of the treating physician, unlikely to be extubated within 48 hours
4. Receiving caffeine therapy
5. Written informed parental consent

Parents of babies recruited at Leeds Teaching Hospitals and Bradford Royal Infirmary will be asked to consent to their
baby having samples taken for cytokine estimation. This will allow modelling of their inflammatory networks

Exclusion Criteria

1. Previously received postnatal steroid treatment for respiratory disease
2. No realistic prospect of survival
3. Severe congenital anomaly affecting the lungs, heart or central nervous system
4. Previous surgical abdominal procedure
5. Concurrent illness for which postnatal corticosteroid would be contra-indicated (e.g. active fungal infection, confirmed or suspected acute sepsis and acute NEC/focal intestinal perforation)
6. Participation in another trial that would preclude baby from inclusion in Minidex

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first extubation after randomisation when the baby remains extubated for more than 24 hours is determined using an intubation log recording times of extubations and re-intubations which will be maintained throughout the intervention period (16 days).