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Protocol for the Birth Asphyxia in African Newborns (Baby BRAiN) Study: a Neonatal Encephalopathy Feasibility Cohort Study.

Webb, Emily L
; 
Mugalu, J
; 
Robertson, Nicola J
; 
Nabawanuka, A
; 
Gilbert, Guillaume
; 
Bwambale, J
; 
Bainbridge, Alan
; 
Lubowa, Samson
; 
Srinivasan, Latha
; 
Ssebombo, H
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Author
Webb, Emily L
 Mugalu, J
 Robertson, Nicola J
 Nabawanuka, A
 Gilbert, Guillaume
 Bwambale, J
 Bainbridge, Alan
 Lubowa, Samson
 Srinivasan, Latha
 Ssebombo, H
 Morgan, Cathy
 Hagmann, Cornelia
 Cowan, Frances M
 Boylan, Geraldine B
 Nakimuli, Annettee
 Tann, Cally J
 Wintermark, Pia
 le doare, kirsty
 Kawooya, Michael
 Martinello, Kathryn
 sadoo, Samantha
 Nanyunja, Carol
 Mambule, Ivan Kiggundu
 mathieson, sean
 Nyirenda, Moffat
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Date
03/03/2022
Date Submitted
Keywords
electroencephalography
low- and middle-income countries
MAGNETIC RESONANCE IMAGING
Magnetic resonance spectroscopy
NEONATAL ENCEPHALOPATHY
Uganda
neurodevelopmental impairment
Outcomes
Other Subjects
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Start Date
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Principal Investigators
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gatesopenres-6-14824.pdf
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URI
https://hdl.handle.net/10147/641211
Abstract
BACKGROUND: Neonatal encephalopathy (NE) is a leading cause of child mortality worldwide and contributes substantially to stillbirths and long-term disability. Ninety-nine percent of deaths from NE occur in low-and-middle-income countries (LMICs). Whilst therapeutic hypothermia significantly improves outcomes in high-income countries, its safety and effectiveness in diverse LMIC contexts remains debated. Important differences in the aetiology, nature and timing of neonatal brain injury likely influence the effectiveness of postnatal interventions, including therapeutic hypothermia. METHODS: This is a prospective pilot feasibility cohort study of neonates with NE conducted at Kawempe National Referral Hospital, Kampala, Uganda. Neurological investigations include continuous video electroencephalography (EEG) (days 1-4), serial cranial ultrasound imaging, and neonatal brain Magnetic Resonance Imaging and Spectroscopy (MRI/ MRS) (day 10-14). Neurodevelopmental follow-up will be continued to 18-24 months of age including Prechtl's Assessment of General Movements, Bayley Scales of Infant Development, and a formal scored neurological examination. The primary outcome will be death and moderate-severe neurodevelopmental impairment at 18-24 months. Findings will be used to inform explorative science and larger trials, aiming to develop urgently needed neuroprotective and neurorestorative interventions for NE applicable for use in diverse settings. DISCUSSION: The primary aims of the study are to assess the feasibility of establishing a facility-based cohort of children with NE in Uganda, to enhance our understanding of NE in a low-resource sub-Saharan African setting and provide infrastructure to conduct high-quality research on neuroprotective/ neurorestorative strategies to reduce death and disability from NE. Specific objectives are to establish a NE cohort, in order to 1) investigate the clinical course, aetiology, nature and timing of perinatal brain injury; 2) describe electrographic activity and quantify seizure burden and the relationship with adverse outcomes, and; 3) develop capacity for neonatal brain MRI/S and examine associations with early neurodevelopmental outcomes.
Language
en
Citation
ISSN
eISSN
2572-4754
ISBN
DOI
10.12688/gatesopenres.13557.1
PMID
35614965
PMCID
PMC9110736
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