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-Outside-EU/EEA

Lead Sponsor: Menzies Institute of Medical Research University of Tasmania

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

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 delivery via a minimally invasive technique in preterm infants 25-28 weeks gestation with RDS treated with CPAP.;Secondary Objective: To evaluate that early surfactant administration via a minimally-invasive technique to preterm infants on CPAP will result in a lesser duration of mechanical respiratory support, and a higher incidence of 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 week gestational age

Secondary Outcome Measures