SurfON: Surfactant or not for babies born early with breathing problems
Not Applicable
- Conditions
- Respiratory and cardiovascular disorders specific to the perinatal periodNeonatal Diseases
- Registration Number
- ISRCTN15915394
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1522
Inclusion Criteria
1. Born at 34+0–38+6 weeks of gestation
2. = 24 hours old
3. Respiratory distress defined as:
3.1. FiO2 = 0.3 and < 0.45 needed to maintain SaO2 = 92%, or
3.2. Clinically significant work of breathing, regardless of FiO2
4. Clinical decision to provide non-invasive respiratory support
5. Written parental informed consent
Exclusion Criteria
1. Major structural or chromosomal abnormality
2. No realistic prospect of survival
3. Prior intubation and/or surfactant administration
4. Known or suspected hypoxic ischaemic encephalopathy
5. Congenital abnormality of the upper or lower respiratory tract
6. Known or suspected neuromuscular disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Length of infant’s hospital stay after birth, defined as the number of days from birth to discharge home from hospital<br> 2. Incidence of severe respiratory failure, defined as, sustained (= 30 minutes) requirement for FiO2 = 0.45 to maintain oxygen saturations (SaO2) = 92%, between trial entry and discharge home from hospital<br>
- Secondary Outcome Measures
Name Time Method