Specialty: Children, Primary sub-specialty: Neonatal
Conditions
Interventions
Babies will be randomised in the ratio 1:1 to receive either very low dose dexamethasone or a matched placebo. Randomisation will be managed via a secure web-based randomisation facility hosted by the
can be increased in line with working weight as per local practice.
Control arm: Participants receive daily intravenous infusions of 50 mcg/kg placebo (0.9% saline solution) for 10 da
can be increased in line with working weight as per local practice.
All participants will be followed up for safety outcomes and other outcomes until 36 weeks postmenstrual age (PMA)
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to first extubation (whether or not more than 24 hours) is measured using the intubation log maintained throughout the intervention period (16 days) 2. Extubation by day 7 after randomisation (where the baby has remained extubated for more than 24 hours) is measured using the intubation log maintained throughout the intervention period (16 days) 3. Extubation by day 7 after randomisation (whether or not for more than 24 hours) is measured using the intubation log maintained throughout the intervention period (16 days) 4. Survival to 36 weeks’ postmenstrual age (or discharge if sooner) is measured using medical record review at 36 weeks’ postmenstrual age 5. Respiratory morbidity to 36 weeks’ postmenstrual age (or discharge home if sooner) is measured by medical record review at 36 weeks’ postmenstrual age (or discharge if sooner) 6. Inflammatory cytokine profile in blood and endotracheal tube secretion fluid is measured from endotracheal tube secretions and blood samples taken at baseline, 4, 7, 10 and 14 days after randomisation 7. Parent/family experience is measured using a parent-completed Diary of Care at maintained throughout the intervention period (16 days) Safety outcomes: 1. Hypertension is reported from medical record review at 36 weeks’ postmenstrual age (or discharge if sooner) 2. Hyperglycaemia is reported from medical record review at 36 weeks’ postmenstrual age (or discharge if sooner) 3. Confirmed/suspected sepsis is reported from medical record review at 36 weeks’ postmenstrual age (or discharge if sooner) 4. Spontaneous gastrointestinal perforation or NEC is reported from medical record review at 36 weeks’ postmenstrual age (or discharge if sooner) 5. Deterioration in cranial ultrasound findings (new finding of severe intraventricular haemorrhage | — |
Countries
United Kingdom
Contacts
Public ContactVaneesha Short
Outcome results
None listed