TY - JOUR
T1 - Protocol for the Birth Asphyxia in African Newborns (Baby BRAiN) Study
T2 - A Neonatal Encephalopathy Feasibility Cohort Study
AU - Tann, Cally J.
AU - Nanyunja, Carol
AU - Sadoo, Samantha
AU - Mambule, Ivan
AU - Mathieson, Sean R.
AU - Nyirenda, Moffat
AU - Webb, Emily L.
AU - Mugalu, J.
AU - Robertson, Nicola J.
AU - Nabawanuka, A.
AU - Gilbert, Guillaume
AU - Bwambale, J.
AU - Martinello, Kathryn
AU - Bainbridge, Alan
AU - Lubowa, Samson
AU - Srinivasan, Latha
AU - Ssebombo, H.
AU - Morgan, Cathy
AU - Hagmann, Cornelia
AU - Cowan, Frances M.
AU - Le Doare, Kirsty
AU - Wintermark, Pia
AU - Kawooya, Michael
AU - Boylan, Geraldine B.
AU - Nakimuli, Annettee
N1 - Publisher Copyright:
© 2022 Nanyunja C et al.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Electroencephalography
KW - Low- and Middle-Income Countries
KW - Magnetic Resonance Imaging
KW - Magnetic Resonance Spectroscopy
KW - Neonatal Encephalopathy
KW - Neurodevelopmental impairment
KW - Outcomes
KW - Uganda
UR - http://www.scopus.com/inward/record.url?scp=85130282680&partnerID=8YFLogxK
U2 - 10.12688/gatesopenres.13557.1
DO - 10.12688/gatesopenres.13557.1
M3 - Article
AN - SCOPUS:85130282680
SN - 2572-4754
VL - 6
JO - Gates Open Research
JF - Gates Open Research
M1 - 10
ER -
