Perinatal Asphyxial Encephalopathy Neonatal Diseases Other disturbances of cerebral status of newborn
Conditions
Interventions
1. Randomisation:
Randomisation will be using sealed envelopes in consecutive eligible infants up to a total of 4 study infants at a time. Forty infants will be randomised to undergo e
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
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 5 on the standardised examination described by Thompson et al (Thompson et al., 1997).
Exclusion criteria
Exclusion criteria: 1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of consent, randomisation and induction and maintenance of therapeutic hypothermia in this setting 2. Information which will optimise the design of a phase III RCT in a low resource setting 3. Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Cranial ultrasound patterns and evolution of injury over the 1st week after birth | — |
Countries
Uganda
Outcome results
None listed