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Open Access Research

Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in uganda: study protocol

Nicola J Robertson12*, Cornelia F Hagmann1, Dominique Acolet3, Elizabeth Allen4, Natasha Nyombi5, Diana Elbourne4, Anthony Costello6, Ian Jacobs12, Margaret Nakakeeto5 and Frances Cowan3

Author Affiliations

1 Institute for Women's Health, 86-96 Chenies Mews, University College London, London, WC1E 6HX, UK

2 Uganda Women's Health Initiative, University College London, London, UK

3 Department of Pediatrics and Imaging Sciences, Imperial College Comprehensive Biomedical Research Centre, London, UK

4 Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London, UK

5 Special Care Baby Unit, Mulago Hospital, Makerere University, Kampala, Uganda

6 International Perinatal Care Unit, Institute of Child Health, London, UK

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Trials 2011, 12:138  doi:10.1186/1745-6215-12-138

Published: 4 June 2011

Abstract

Background

There is now convincing evidence that in industrialized countries therapeutic hypothermia for perinatal asphyxial encephalopathy increases survival with normal neurological function. However, the greatest burden of perinatal asphyxia falls in low and mid-resource settings where it is unclear whether therapeutic hypothermia is safe and effective.

Aims

Under the UCL Uganda Women's Health Initiative, a pilot randomized controlled trial in infants with perinatal asphyxia was set up in the special care baby unit in Mulago Hospital, a large public hospital with ~20,000 births in Kampala, Uganda to determine:

(i) The feasibility of achieving consent, neurological assessment, randomization and whole body cooling to a core temperature 33-34°C using water bottles

(ii) The temperature profile of encephalopathic infants with standard care

(iii) The pattern, severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome

(iv) The feasibility of neurodevelopmental follow-up at 18-22 months of age

Methods/Design

Ethical approval was obtained from Makerere University and Mulago Hospital. All infants were in-born. Parental consent for entry into the trial was obtained. Thirty-six infants were randomized either to standard care plus cooling (target rectal temperature of 33-34°C for 72 hrs, started within 3 h of birth) or standard care alone. All other aspects of management were the same. Cooling was performed using water bottles filled with tepid tap water (25°C). Rectal, axillary, ambient and surface water bottle temperatures were monitored continuously for the first 80 h. Encephalopathy scoring was performed on days 1-4, a structured, scorable neurological examination and head circumference were performed on days 7 and 17. Cranial ultrasound was performed on days 1, 3 and 7 and scored. Griffiths developmental quotient, head circumference, neurological examination and assessment of gross motor function were obtained at 18-22 months.

Discussion

We will highlight differences in neonatal care and infrastructure that need to be taken into account when considering a large safety and efficacy RCT of therapeutic hypothermia in low and mid resource settings in the future.

Trial registration

Current controlled trials ISRCTN92213707