Which oxygen saturation level should we use for very premature infants? A randomised controlled trial (BOOST-II UK) - BOOST-II UK
- Conditions
- Respiratory distress of newbornICD codes P22.0, P22.8, P22.9
- Registration Number
- EUCTR2005-006174-97-IE
- Lead Sponsor
- niversity of Oxford, Research Governance & Clinical Trials Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
Inclusion Criteria
Infants are eligible if they are:
(a) they are less than 28 weeks’ gestation at birth and
(b) they are less than 12 hours old (24 hours old if the baby is outborn) and
(c) the clinician and parents are substantially uncertain which SpO2 is better and
(d) the parent(s) have given written informed consent to their baby’s participation
Are the trial subjects under 18? yes
Number of subjects for this age range:
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
Recruitment is not appropriate if there is no realistic prospect of survival, or follow-up is unlikely to be possible.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method