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Clinical Trials/EUCTR2005-006174-97-GB
EUCTR2005-006174-97-GB
Active, Not Recruiting
Phase 1

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 sites0 target enrollmentMay 15, 2007

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Oxford, Research Governance & Clinical Trials Office
Status
Active, Not Recruiting
Last Updated
5 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 15, 2007
End Date
January 6, 2011
Last Updated
5 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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