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.
Minidex is a multi-centre randomised controlled trial comparing low dose dexamethasone to placebo for premature babies who are breathing with the support of a ventilator. We would like to find out if low dose dexamethasone is helpful, harmful, or makes no difference to the outcomes for these babies. Our early research suggests that it is helpful and with fewer side effects.
Premature babies who need a ventilator for a long time are at risk of developing a lung condition called bronchopulmonary dysplasia (BPD, sometimes called chronic lung disease). This is caused, in part, by inflammation of the baby’s developing lungs. This inflammation is likely to be made worse by the ventilator. When this happens, the baby needs more oxygen and may have difficulty breathing, which can take some time to improve. Babies with BPD generally stay in hospital longer and are more likely to have issues with their brain development.
In some countries, premature babies are given a steroid as soon as they are born to prevent BPD. There is some evidence that this works. However in the UK, doctors prefer not to give steroids to every premature baby because most premature babies don’t get BPD. Doctors in the UK prefer to give steroid treatment only to babies who are most at risk of BPD when they are a couple of weeks old. This is so the risk of side effects is balanced by the benefits of treatment.
At present, many babies in the UK who need a ventilator for a long time and are at high risk of developing BPD are treated with a steroid called dexamethasone. Dexamethasone is used in many conditions to reduce inflammation in the body. In the past, doctors used to use high doses of dexamethasone to get babies off ventilators. These high doses did help babies came off the ventilators earlier with fewer lung problems, but there were side effects. There are also concerns that the doses used are higher than is necessary.
The focus of this trial is to target dexamethasone treatment to just those babies who are most likely to need it, and use a lower dose of steroid than used in the past. The study will find out if this reduced dose, ‘Minidex’, is helpful, harmful or makes no difference to the outcomes of these babies.
- EudraCT No.:
- REC Reference:
- Clinical Trials Unit:
- National Perinatal Epidemiology Unit CTU
- Liverpool Women's Foundation NHS Trust
- The NIHR Efficacy and Mechanism Evaluation (EME) Programme
To determine if treatment with very low dose dexamethasone facilitates the extubation (for more than 24 hours) of ventilator dependent preterm babies of less than 30 weeks’ gestation who are at high risk of developing BPD.
To determine if the treatment of ventilator dependent preterm babies of less than 30 weeks’ gestation who are at high risk of developing BPD with very low dose dexamethasone impacts upon:
- Time to first extubation after first IMP dose (whether or not more than 24 hours)
- Extubation (for more than 24 hours) by day 7
- Extubation (whether or not more than 24 hours) by day 7
- Survival to 36 weeks’ postmenstrual age (PMA)
- Respiratory morbidity to 36 weeks’ PMA (or discharge home if sooner)
- Safety outcomes
- Parent/family experience
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