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Clinical Trials/CTRI/2011/06/001780
CTRI/2011/06/001780
Completed
未知

Therapeutic hypothermia for term neonates with perinatal asphyxia

Dr Vishnu Bhat B0 sites120 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Term neonates with perinatal asphyxia
Sponsor
Dr Vishnu Bhat B
Enrollment
120
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
Dr Vishnu Bhat B

Eligibility Criteria

Inclusion Criteria

  • Inborn babies \- 1\.Gestational age ≥ 37 weeks
  • 2\.ABG(umbilical cord or 1st postnatal hour)
  • pH ≤7 or BE ≥ \-12
  • 3\.Evidence of encephalopathy
  • 4\.Any two of the following
  • i. APGAR ≤6 at 5 min
  • ii. Evidence of fetal distress
  • iii. Assisted ventilation for atleast 10 min after birth
  • iv. Evidence of any organ dysfunction
  • v. History of acute perinatal event\-

Exclusion Criteria

  • i. Infants 6 hours of age at the time of
  • randomization.
  • ii.Major congenital abnormalies
  • iii. If the baby does not establish spontaneous
  • respiration by 20 minutes
  • iv. outborn babies

Outcomes

Primary Outcomes

Not specified

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