Premature infants between 25 and 28 weeks gestation may develop lung disease and require respiratory support of continuous positive airway pressure (CPAP). The trial is looking at if there is a benefit from giving a medication called surfactant at an early stage, delivered via a narrow tube briefly placed into the windpipe.
- Conditions
- Respiratory Distress Syndrome in Premature Babies.Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-005429-21-NL
- Lead Sponsor
- Menzies Institute of Medical Research University of Tasmania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 606
1. Requiring CPAP or nasal IPPV because of respiratory distress.
2. CPAP pressure of 5-8 cm H2O and FiO2 =0.30.
3. Less than 6 hours of age.
4. Agreement of the Treating Physician in charge of the infant’s care.
5. Signed parental consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 606
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method