Journal Article

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

Allen, Elizabeth, Nakakeeto, Margaret, Acolet, Dominique, Robertson, Nicola J, Hagmann, Cornelia F, Cowan, Frances, Elbourne, Diana, Jacobs, Ian, Nyombi, Natasha, Costello, Anthony

2011

Overview

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: The feasibility of achieving consent, neurological assessment, randomization and whole body cooling to a core temperature 33-34°C using water bottles The temperature profile of encephalopathic infants with standard care The pattern, severity and evolution of brain tissue injury as seen on cranial ultrasound and relation with outcome The feasibility of neurodevelopmental follow-up at 18-22 months of age Methods/Design Ethical approval was obtained from Makerere Unive r sity 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

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Asphyxia Neonatorum - complications / Asphyxia Neonatorum - economics / Babies / Biomedicine / Body Temperature Regulation / Care and treatment / Cephalometry / Cerebral palsy / Consent / Developing Countries - economics / Diagnosis / Encephalopathy / Feasibility Studies / Health aspects / Health Resources - economics / Health Sciences / Hospital Costs / Hospitals / Hospitals, Public - economics / Humans / Hypothermia / Hypothermia, Induced - economics / Hypoxia-Ischemia, Brain - diagnostic imaging / Hypoxia-Ischemia, Brain - economics / Hypoxia-Ischemia, Brain - etiology / Hypoxia-Ischemia, Brain - physiopathology / Hypoxia-Ischemia, Brain - therapy / Industrialized nations / Infant / Infant, Newborn / Low income groups / Medicine / Medicine & Public Health / Mortality / Motor Skills / Neurologic Examination / Newborn babies / Nurses / Nursing care / Pilot Projects / Predictive Value of Tests / Sepsis / Severity of Illness Index / Statistics for Life Sciences / Time Factors / Traumatic brain injury / Treatment Outcome / Uganda / Ultrasonic imaging / Ultrasonography / Ultrasound imaging / Womens health