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.


Robertson, NJ; Hagmann, CF; Acolet, D; Allen, E; Nyombi, N; Elbourne, D; Costello, A; Jacobs, I; Nakakeeto, M; Cowan, F; (2011) 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. Trials, 12 (1). p. 138. ISSN 1745-6215 DOI: https://doi.org/10.1186/1745-6215-12-138

[img]
Preview
Text - Published Version
License:

Download (1MB) | Preview

Abstract

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 33-34oC 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: 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 33-34oC for 72 hrs, started within 3h 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 (25oC). Rectal, axillary, ambient and surface water bottle temperatures were monitored continuously for the first 80h. 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.

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Medical Statistics
Research Centre: Centre for Maternal, Reproductive and Child Health (MARCH)
Centre for Global Non-Communicable Diseases (NCDs)
PubMed ID: 21639927
Web of Science ID: 292329400001
URI: http://researchonline.lshtm.ac.uk/id/eprint/639

Statistics


Download activity - last 12 months
Downloads since deposit
270Downloads
348Hits
Accesses by country - last 12 months
Accesses by referrer - last 12 months
Impact and interest
Additional statistics for this record are available via IRStats2

Actions (login required)

Edit Item Edit Item