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Clinical Trials/CTRI/2016/01/006534
CTRI/2016/01/006534
Recruiting
Phase 3

Hypothermia for Encephalopathy in Low and Middle Income Countries Trial - HELIX

Imperial college London0 sites408 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Imperial college London
Enrollment
408
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Inclusion Criteria (ALL THE THREE BELOW)
  • •1\.Age \< 6 hours, Birth\-weight \>1\.8 kg, Gestation \>36 weeks
  • •2\.Need for continued resuscitation at 5 minutes after birth and/or 5 minute Apgar score \<6 (in babies born at hospital) or lack of cry by 5 minutes of age (for babies born at home)
  • •3\.Evidence of moderate or severe encephalopathy on clinical examination within 6 hours of age.

Exclusion Criteria

  • •Exclusion Criteria
  • •1\.Absent heart rate at 10 minute of age despite adequate resuscitation.
  • •2\.Major life threatening congenital malformation.
  • •3\.Migrant family or parents unable/unlikely to come back for follow up at 18 months.
  • •4\.Lack of parental consent.

Outcomes

Primary Outcomes

Not specified

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