Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airway pressure

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Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 25-28 weeks gestation treated with continuous positive airway pressure (CPAP)? A multicentre, randomised, masked, controlled trial will be conducted in inborn preterm infants 25-28 weeks gestation, aged less than 6 hours, requiring CPAP because of respiratory distress, with an FiO2 of >=0.3 and CPAP pressure 5-8. Infants randomised to surfactant treatment will receive 200 mg/kg of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter, followed by reinstitution of CPAP. Controls will continue on CPAP. The intervention will be masked from the clinical team. Care thereafter will be as per usual in both groups, other than the requirement to adhere to intubation criteria. The primary outcome will be incidence of death or BPD. Secondary outcomes will include incidence of death, major neonatal morbidities (BPD, intraventricular haemorrhage, periventricular leukomalacia, retinopathy of prematurity, necrotising enterocolitis), pneumothorax and patent ductus arteriosus; need for intubation and surfactant therapy; durations of mechanical respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal cannula (HFNC), oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; applicability and safety of the MIST procedure; and outcome at 2 years. The sample size will be 303/group, allowing detection of a 33% difference in the primary outcome with 90% power. The trial commenced at Royal Hobart Hospital December 2011 and Royal Women's Hospital during 2012, and will ultimately be conducted over 7 years in multiple centres nationally and overseas. Followup: at 2 years corrected age, parents of each infant will complete a brief health assessment and a validated child development assessment (PARCA-R, Dev Med Child Neurol 2004;46:389–97) administered as a web-based questionnaire located on a secure server. No identifying details will be revealed in the completion of the questionnaire. Health information to be collected will include duration of oxygen therapy at home, details of hospitalisations in the first 2 years (age, duration and classification of illness [respiratory/non-respiratory]), whether immunized against respiratory syncytial virus and influenza, family history of asthma, details of respiratory symptoms (respiratory distress and wheezing) and medications, details of feeding, vision and hearing capabilities, and presence and severity of motor problems. The PARCA-R questionnaire will seek information on the child’s development and speech.