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Clinical Trials/ISRCTN87351483
ISRCTN87351483
Completed
Not Applicable

Randomised controlled trial of early versus late initiation of milk feeds for infants with absent or reversed end diastolic flow velocities (AREDFV) or cerebral redistribution

niversity of Oxford (UK)0 sites400 target enrollmentSeptember 30, 2004
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Oxford (UK)
Enrollment
400
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 30, 2004
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Oxford (UK)

Eligibility Criteria

Inclusion Criteria

  • •Infants admitted to participating neonatal units and satisfying all of the following criteria may be recruited into the study:
  • •1\. Gestational age up to and including 34 weeks \+ 6 days
  • •2\. Antenatal ultrasound showing either:
  • •2\.1\. Absent or reversed end diastolic flow velocities on at least 50% of the Doppler waveforms from the umbilical artery on at least one occasion during pregnancy, or
  • •2\.2\. Cerebral redistribution, defined as occurring when both the umbilical artery pulsatility index is greater than the 95th centile and the middle cerebral artery pulsatility index is less that the 5th centile for gestational age
  • •3\. Small for gestational age
  • •4\. Postnatal age 20 \- 48 hours

Exclusion Criteria

  • •Infants will be excluded if any of the following factors are present:
  • •1\. Major congenital abnormality including known chromosomal abnormality
  • •2\. Twin\-twin transfusion
  • •3\. Intra\-uterine transfusion or exchange transfusion
  • •4\. Rhesus iso\-immunisation
  • •5\. Significant multi\-organ failure prior to trial entry
  • •6\. Inotropic drug support prior to trial entry
  • •7\. Already received any enteral feeding

Outcomes

Primary Outcomes

Not specified

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