The OPTIMIST-A Trial
Research type
Research Study
Full title
Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airway pressure (CPAP)
IRAS ID
143117
Contact name
Howard CLARK
Contact email
Sponsor organisation
Menzies Research Institute Tasmania
Eudract number
2013-005429-21
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
12611000916943, Australian and New Zealand Clinical Trials Registry
Duration of Study in the UK
3 years, 10 months, 31 days
Research summary
This research is a clinical trial investigating a new and less-invasive technique of giving an approved medication called surfactant to improve lung function in premature babies. The group to be studied are premature infants born between 25 and 28 weeks gestation. Such infants usually need respiratory support, which has historically been in the form of full ventilation via a breathing tube, through which surfactant could routinely be given into the windpipe to help mature the lungs. Nowadays, infants in this gestation range are increasingly being managed from the outset with respiratory support via a nasal mask or prongs (continuous positive airway pressure, CPAP), rather than full ventilation. This means that the usual technique of giving surfactant cannot be carried out, and surfactant is thus not given unless the infant goes on to require ventilation via the breathing tube. The OPTIMIST-A trial is looking at whether giving surfactant at an early stage using a thin tube (catheter) passed briefly into the windpipe is advantageous for a preterm baby on CPAP. We are studying whether giving surfactant using the thin catheter will result in better outcomes, including a reduction in time on respiratory support, and higher survival without chronic oxygen dependency.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
16/SC/0216
Date of REC Opinion
29 Jul 2016
REC opinion
Further Information Favourable Opinion