Premature infants between 25 and 28 weeks gestation may develop lungdisease and require respiratory support of continuous positive airwaypressure (CPAP). The trial is looking at if there is a benefit from giving amedication called surfactant at an early stage, delivered via a narrowtube briefly placed into the windpipe.

Conditions: Respiratory Distress Syndome in Premature Babies
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-005429-21-SI

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

Inclusion Criteria

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

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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate in a randomised controlled trial the efficacy of surfactant<br>delivery via a minimally invasive technique in preterm infants 25-28<br>weeks gestation with RDS treated with CPAP.;Secondary Objective: To evaluate that early surfactant administration via a minimallyinvasive<br>technique to preterm infants on CPAP will result in a lesser<br>duration of mechanical respiratory support, and a higher incidence of<br>survival without bronchopulmonary dysplasia.;Primary end point(s): Incidence of composite outcome of death or physiological BPD;Timepoint(s) of evaluation of this end point: 36 weeks gestational age

Secondary Outcome Measures