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Clinical Trials/ISRCTN72635512
ISRCTN72635512
Completed
Not Applicable

Assessing the neuro-protective effect of mild cooling in neonates receiving extra-corporeal membrane oxygenation (ECMO): a randomised controlled trial

niversity Hospitals of Leicester NHS Trust (UK)0 sites118 target enrollmentSeptember 21, 2005
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospitals of Leicester NHS Trust (UK)
Enrollment
118
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 21, 2005
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospitals of Leicester NHS Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •Babies recruited to the study must be the existing standard criteria for ECMO eligibility.
  • •These include:
  • •1\. To be at least 35 weeks gestation
  • •2\. To be at least 2000 g birth weight
  • •3\. To have no uncontrolled bleeding disorder
  • •4\. To have no congenital or acquired central nervous system (CNS) disorder
  • •5\. To have undergone no more than 7 consecutive days of high pressure ventilation prior to referral for ECMO
  • •6\. To be suffering from a condition which is potentially reversible
  • •7\. To have evidence of severe cardio respiratory failure
  • •8\. Less than 29 days of age, either sex

Exclusion Criteria

  • •1\. All neonates referred with diaphragmatic hernia
  • •2\. All neonates receiving ECMO for post operative cardiac support
  • •Added 19/05/10:
  • •3\. All neonates who have been cooled prior to ECMO

Outcomes

Primary Outcomes

Not specified

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