Therapeutic Hypothermia for Birth Asphyxia in a Low Resource Setting

Not Applicable

Completed

• Conditions: Perinatal Asphyxial Encephalopathy; Neonatal Diseases; Other disturbances of cerebral status of newborn

• Registration Number: ISRCTN92213707
• Lead Sponsor: niversity College London

Brief Summary

2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21639927 2008 results in https://doi.org/10.1016/S0140-6736(08)61329-X (added 20/02/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-10-31
• Study Start: 2010-06-28
• Last Update Posted: 3 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Study infants will be near term or full term infants with:
1. Need for resuscitation with assisted bag and mask ventilation after birth and/or an Apgar score of <6 at 5 minutes (10 minutes
if available)
2. Abnormal neurological assessment between 30 mins and 3 hrs of age
An abnormal neurological examination at 30 mins will be defined as a score >5 on the standardised examination described by
Thompson et al (Thompson et al., 1997).

Exclusion Criteria

1. <35 weeks gestation or birthweight < 2000g
2. Onset of regular breathing delayed > 20 mins or those who remain apnoeic and cyanotic
3. Absent cardiac output > 10 mins
4. > 3 hrs of age at study entry
5. Major malformations
6. Symptomatic infection
7. Metabolic disease suspected at time of randomisation
8. Families who live >20 km radius of Mulago Hospital
9. Out born infants
10. Those parents who do not speak or understand either English or Luganda or any parent who does not understand the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified