Continuous positive airway pressure (CPAP) or Synchronised intermittent positive airway pressure (SiPAP™) study

Not Applicable

Completed

• Conditions: Respiratory distress syndrome; Pregnancy and Childbirth; Respiratory distress of newborn

• Registration Number: ISRCTN15997073
• Lead Sponsor: South Tees Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-12
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Gestational age - 28+0 to 31+6 weeks by scan estimated date of delivery (EDD) inclusive
2. Signs of respiratory distress requiring non-invasive respiratory support
3. Inborn
4. Signed written parental consent for participation
5. Randomised by 6 hours of age or less

Exclusion Criteria

1. Gestational age - less than 27+6 weeks or greater than 32+0 weeks
2. Endotracheal intubation and ventilation at any time prior to enrolment
3. Respiratory distress meeting failure criteria of non-invasive ventilation and requiring intubation and mechanical ventilation
4. Congenital or neuromuscular disorders diagnosed antenatally or at the time of birth, known to interfere with respiratory function or ability to breathe; including significant abnormalities of the upper airway
5. Refusal of signed written parental consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure of non-invasive ventilation necessitating intubation and mechanical ventilation (placement of a tube in the windpipe and full artificial breathing support via machine) in the first 72 hours of treatment with either CPAP or SiPAP™. This outcome is binary categoric as babies will be either 'intubated and mechanically ventilated' or not; providing a proportion of infants in each treatment arm who meet this outcome.