None listed
Conditions
Brief summary
Research question: Does administration of exogenous surfactant using a minimally-invasive technique improve outcome in preterm infants 29-32 weeks gestation treated with continuous positive airway pressure (CPAP)? A multicentre, randomised, masked, controlled trial will be conducted in preterm infants 29-32 weeks gestation, aged less than 12 hours, requiring CPAP because of respiratory distress, with an FiO2 of >=0.32 (CPAP pressure 5-6) or >=0.28 (CPAP pressure 7-8). Infants randomised to surfactant treatment will receive 100 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 duration of respiratory support (all hours of intubation, CPAP and high flow nasal cannula). Secondary outcomes will include Need for intubation and surfactant therapy; durations of intubation, CPAP, intubation and CPAP, HFNC, oxygen therapy, intensive care stay and hospitalisation; hospitalisation cost; incidence of death, major neonatal morbidities, pneumothorax and patent ductus arteriosus; and applicability and safety of the MIST procedure. The sample size will be 227/group, allowing detection of a 25% reduction in duration of respiratory support with 90% power. The trial will commence at Royal Hobart Hospital and Royal Women's Hospital during 2011, and will ultimately be conducted over 5 years in multiple centres nationally and overseas.
Interventions
Minimally invasive surfactant therapy - delivery of exogenous surfactant to the lung via brief catheterisation of the trachea with an instillation catheter in a preterm infant who is being supported with continuous positive airway pressure (CPAP) via nasal prongs or mask. The surfactant dose will be 100 mg/kg, administered over 15 - 30 seconds. Total duration of the procedure will be less than 5 minutes, followed by reinstitution of CPAP. Only a single dose will be given within the first 12 hour
Minimally invasive surfactant therapy - delivery of exogenous surfactant to the lung via brief catheterisation of the trachea with an instillation catheter in a preterm infant who is being supported with continuous positive airway pressure (CPAP) via nasal prongs or mask. The surfactant dose will be 100 mg/kg, administered over 15 - 30 seconds. Total duration of the procedure will be less than 5 minutes, followed by reinstitution of CPAP. Only a single dose will be given within the first 12 hours of life.
Sponsors
Menzies Institute of Medical Research, University of Tasmania
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 12 Hours
Healthy volunteers
No
Inclusion criteria
1. Gestational age 29-32 completed weeks 2. Requiring CPAP with signs of early respiratory distress. 3. CPAP pressure of 5-6 cm H2O and FiO2 >=0.32, or a CPAP pressure 7-8 cm H2O and FiO2 >=0.28. 4. Less than 12 hours of age. 5. Agreement of the Treating Physician in charge of the infant’s care. 6. Signed parental consent.
Exclusion criteria
1. Previously intubated, or in imminent need of intubation because of respiratory distress, apnoea or persistent acidosis. 2. Congenital anomaly or condition that might adversely affect breathing. 3. Identifiable alternative cause for respiratory distress (e.g. congenital pneumonia or pulmonary hypoplasia). 4. Lack of availability of an OPTIMIST treatment team.
Outcome results
None listed