MULTICENTRE RANDOMISED CONTROLLED TRIAL<br>OF MINIMALLY-INVASIVE SURFACTANT THERAPY IN<br>PRETERM INFANTS 25-28 WEEKS GESTATION<br>ON CONTINUOUS POSITIVE AIRWAY PRESSURE
Completed
- Conditions
- 10028920respiratoire insufficientierespiratory distress syndrome (RDS)10028971
- Registration Number
- NL-OMON44166
- Lead Sponsor
- Menzies Research Institute Tasmania, University of Tasmania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Preterm infants 25-28 weeks gestation
2. Requiring CPAP or nasal IPPV because of respiratory distress.
3. CPAP pressure of 5-8 cm H2O and Fi (fractional inspiratory) O2 * 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome: Incidence of composite outcome of death or physiological<br /><br>bronchopulmonary dysplasia (BPD).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes: Incidence of death, major neonatal morbidities (BPD,<br /><br>intraventricular haemorrhage, periventricular leukomalacia, retinopathy of<br /><br>prematurity, necrotising enterocolitis), pneumothorax and patent ductus<br /><br>arteriosus; need for intubation and surfactant therapy; durations of mechanical<br /><br>respiratory support, intubation, CPAP, intubation and CPAP, high flow nasal<br /><br>cannula, oxygen therapy, intensive care stay and hospitalisation;<br /><br>hospitalisation cost; applicability and safety of the MIST procedure; and<br /><br>outcome at 2 years.</p><br>