Minidex
Research type
Research Study
Full title
Minidex: 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
IRAS ID
191940
Contact name
Mark Turner
Contact email
Eudract number
2015-005342-63
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Premature babies who require prolonged breathing support through a breathing tube (ventilation) are at risk of developing a lung condition called bronchopulmonary dysplasia (BPD). BPD affects approximately 25% of babies born at less than 30 weeks gestation who survive to discharge. It prolongs hospitalisation and is associated with a significant long term respiratory and neurodevelopmental healthcare burden: each year up to 200 UK babies develop moderate or severe disability attributable to BPD. \n\nPrevious research shows that large doses of dexamethasone reduces inflammation in the lungs, changing the way they work, so babies need less breathing support and have fewer long term breathing problems. A side effect of treatment with large doses of dexamethasone is a possible increase in the risk of cerebral palsy or learning difficulties. To reduce the risk of brain damage some Neonatologists now use very small doses of dexamethasone in babies with severe lung problems who are at high risk of developing BPD. They hope that the doses used are sufficient to help the baby’s lungs while being small enough to avoid damaging the developing brain. At present there is no evidence to support this theory. We do not know if the doses used help prevent BPD or affect brain development.\n\nThis project asks whether giving a very low doses of dexamethasone to a baby on a ventilator at high risk of BPD will help the baby come off the ventilator. We will use a dose of dexamethasone that is ten times lower than the previously studied higher dose. This dose appears to be effective and cause fewer side effects. The study will find out if this reduced dose, ’minidex’ is helpful, harmful or makes no difference to the outcomes of these babies.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0396
Date of REC Opinion
21 Jun 2016
REC opinion
Further Information Favourable Opinion