ACTRN12611000917932Not yet recruitingPhase 3
Multicentre randomised controlled trial in preterm infants 29-32 weeks gestation on continuous positive airway pressure of the effect of minimally-invasive surfactant therapy in comparison to standard care (continuation of CPAP) on the duration of respiratory support (all hours of intubation, nasal CPAP and high flow nasal cannula).
Menzies Institute of Medical Research, University of Tasmania0 sites454 target enrollmentStarted: August 26, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 454
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- Hours to 12 Hours (—)
- Sex
- All
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.
Investigators
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