Mindex: The efficacy and safety of very low dose dexamethasone used to facilitate the extubation of ventilator dependent preterm babies who are at high risk of bronchopulmonary dysplasia - Minidex

niversity of Liverpool0 个研究点目标入组 22 人开始时间: 2018年9月13日最近更新: 2019年2月28日

适应症

试验速览

暂无简介。

•Inclusion Criteria
•Eligible babies:
•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 ET tube with at least 30% inspired oxygen when the 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
•6. Born to a mother aged 16 or over
•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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 94
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 0
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Exclusion Criteria
•Ineligible babies:
•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

发起方

niversity of Liverpool