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Clinical Trials/EUCTR2005-006174-97-IE
EUCTR2005-006174-97-IE
Active, Not Recruiting
N/A

Which oxygen saturation level should we use for very premature infants? A randomised controlled trial (BOOST-II UK) - BOOST-II UK

niversity of Oxford, Research Governance & Clinical Trials Office0 sites1,200 target enrollmentSeptember 6, 2007
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ConditionsRespiratory distress of newbornICD codes P22.0, P22.8, P22.9

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiratory distress of newbornICD codes P22.0, P22.8, P22.9
Sponsor
niversity of Oxford, Research Governance & Clinical Trials Office
Enrollment
1200
Status
Active, Not Recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 6, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Oxford, Research Governance & Clinical Trials Office

Eligibility Criteria

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

Exclusion Criteria

  • •Recruitment is not appropriate if there is no realistic prospect of survival, or follow\-up is unlikely to be possible.

Outcomes

Primary Outcomes

Not specified

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