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Clinical Trials/PACTR202006515915908
PACTR202006515915908
Completed
未知

A comparative study of neuroprotective strategies in neonatal hypoxic ischaemic encephalopathy

SAMRC0 sites40 target enrollmentJune 11, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Neonatal Diseases
Sponsor
SAMRC
Enrollment
40
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 11, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
SAMRC

Eligibility Criteria

Inclusion Criteria

  • 1\) 36 weeks gestation or greater
  • 2\) Birthweight of at least 1\.8kg.
  • 3\) At least one of the following:
  • a) need for resuscitation for \=10 minutes,
  • b) Apgar score \=7 at 10 minutes,
  • c)pH \=7 or base deficit \=16 on cord gas or infant blood within an hour of birth.
  • 4\) Seizures, or moderate to severe encephalopathy on clinical grounds, or a Thompson HIE score of at least 10
  • 5\) Less than 6 hours old at initiation of cooling

Exclusion Criteria

  • 1\) Less than 36 weeks
  • 2\) Birthweight less than 1\.8kg.
  • 3\) Not meeting at least one of the following:
  • a) need for resuscitation for \=10 minutes,
  • b) Apgar score \=7 at 10 minutes,
  • c)pH \=7 or base deficit \=16 on cord gas or infant blood within an hour of birth.
  • 4\) No Seizures and NO moderate to severe encephalopathy on clinical grounds, or a Thompson HIE score of at least 10
  • 5\) Older than 6 hours
  • 6\) congenital abnormalities
  • 7\) infants in whom intensive care is withdrawn

Outcomes

Primary Outcomes

Not specified

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