Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 29-32 weeks gestation on continuous positive airway pressure

Phase 3

• Conditions: eonatal respiratory distress syndrome; Neonatal respiratory distress syndrome; Respiratory - Other respiratory disorders / diseases; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12611000917932
• Lead Sponsor: Menzies Institute of Medical Research, University of Tasmania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 454

Inclusion Criteria

1. Gestational age 29-32 completed weeks
2. Requiring CPAP with signs of early respiratory distress.
3. CPAP pressure of 5-6 cm H2O and FiO2 >=0.32, or a CPAP pressure 7-8 cm H2O and FiO2 >=0.28.
4. Less than 12 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