A comparative study of neuroprotective strategies in neonatal hypoxic ischaemic encephalopathy

Not Applicable

• Conditions: Neonatal Diseases

• Registration Number: PACTR202006515915908
• Lead Sponsor: SAMRC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

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7) infants in whom intensive care is withdrawn

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: to determine whether combining therapeutic hypothermia with another neuroprotective strategy (ie. morphine) improves survival to 18 months of age, and improves survival without major disability at 18 months of age.

Secondary Outcome Measures

Name	Time	Method
Correlation of several biomarkers with the severity of the primary injury and outcome will be evaluated.