ACTRN12611000916943
Terminated
未知
Multicentre randomised controlled trial in preterm infants 25-28 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 incidence of the composite outcome of death or physiological BPD.
Menzies Institute of Medical Research University of Tasamania0 sites486 target enrollmentAugust 26, 2011
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Menzies Institute of Medical Research University of Tasamania
- Enrollment
- 486
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Gestational age 25\-28 completed weeks 2\. Requiring CPAP with signs of early respiratory distress. 3\. CPAP pressure of 5\-8 cm H2O and FiO2 \>\=0\.30\. 4\. Less than 6 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.
Outcomes
Primary Outcomes
Not specified
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