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Validation of neurodevelopmental assessments for early detection of high-risk infants in Zimbabwe: protocol for the Child Development Observation study (ChiDO study).

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Title: Validation of neurodevelopmental assessments for early detection of high-risk infants in Zimbabwe: protocol for the Child Development Observation study (ChiDO study).
Authors: Mudawarima L; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe., Santos N; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California, USA., Chimhini GL; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe., Mujuru HA; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe., Magonya R; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe., Ghosh R; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California, USA., Martin-Herz SP; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California, USA Susanne.MartinHerz@ucsf.edu.; Pediatrics, University of California San Francisco School of Medicine, San Francisco, California, USA.
Source: BMJ paediatrics open [BMJ Paediatr Open] 2026 Sep 19; Vol. 10 (1). Date of Electronic Publication: 2026 Sep 19.
Publication Type: Journal Article; Validation Study
Language: English
Journal Info: Publisher: BMJ Publishing Group Country of Publication: England NLM ID: 101715309 Publication Model: Electronic Cited Medium: Internet ISSN: 2399-9772 (Electronic) Linking ISSN: 23999772 NLM ISO Abbreviation: BMJ Paediatr Open Subsets: MEDLINE
Imprint Name(s): Original Publication: London : BMJ Publishing Group, [2017]-
MeSH Terms: Neurodevelopmental Disorders*/diagnosis , Neurodevelopmental Disorders*/etiology , Asphyxia Neonatorum*/complications , Developmental Disabilities*/diagnosis , Child Development*, Humans ; Zimbabwe ; Infant ; Prospective Studies ; Longitudinal Studies ; Early Diagnosis ; Female ; Infant, Newborn ; Neurodevelopment ; Male ; Resource-Limited Settings ; Child, Preschool ; Research Design ; Risk Assessment
Abstract: Introduction: Appropriate neurodevelopmental assessment tools are often unavailable in low- and middle-income countries (LMICs) due to lack of validation, cost and cultural-linguistic challenges. This reduces the availability of high-quality developmental evaluation, resulting in clinical gaps that impact individual child outcomes and modifiable risk detection for prevention. The objective of this study is to validate three neurodevelopmental assessment tools for early detection in low-resource settings through recruitment of infants across the neurodevelopmental impairment (NDI) risk spectrum related to perinatal asphyxia and neonatal encephalopathy (NE).
Methods: This prospective, longitudinal cohort study in Harare, Zimbabwe will collect data at 3 months, 6 months, 12 months, 18 months and 24 months. The sample of approximately 600 caregiver-infant dyads will include: (1) infants without clinical concern for perinatal asphyxia or other complications (low risk); (2) infants who do not cry at birth and require resuscitation but do not have NE (moderate risk) and (3) infants who experience NE (high risk). In addition to demographic, antenatal and perinatal data collected at enrolment, neurodevelopmental assessments to be conducted include the Prechtl General Movement Assessment (GMA); Hammersmith Infant Neurological Examination (HINE); Global Scales for Early Development (GSED); Mullen Scales of Early Learning (MSEL) and caregiver-reported Ages and Stages Questionnaire. At the 24-month visit, a comprehensive diagnostic evaluation for NDI will be conducted adhering to international guidance. Predictive ability of all tools will be assessed by receiver operating characteristic (ROC) analyses, including area under the ROC curve. Construct validity of the GSED will be assessed by comparing to the MSEL. The GSED's ability to differentiate subgroups defined by correlates of NDI risk will be assessed using generalised estimating equations.
Ethics and Dissemination: Ethical approvals have been obtained. If shown to be valid, the GMA and HINE could provide earlier, feasible and low-cost detection of children at elevated risk for NDI.
(© World Health Organization 2026. Licensee BMJ.)
Competing Interests: Competing interests: SPMH serves as a technical advisor for the World Health Organization Brain Health Unit which oversees and coordinates research and programming related to the Global Scales for Early Development. All other authors have no competing interest to declare.
References: Neonatology. 2018;114(4):341-347. (PMID: 30130752)
BMC Public Health. 2025 Feb 10;25(1):535. (PMID: 39930359)
J Clin Med. 2023 May 20;12(10):. (PMID: 37240681)
Cureus. 2025 Feb 7;17(2):e78719. (PMID: 40065858)
S Afr J Commun Disord. 2018 Mar 08;65(1):e1-e9. (PMID: 29781700)
Dev Med Child Neurol. 2024 Aug;66(8):990-1012. (PMID: 38351549)
BMJ Glob Health. 2025 Apr 02;10(4):. (PMID: 40180429)
Acta Paediatr. 1997 Jul;86(7):757-61. (PMID: 9240886)
AIDS Care. 2020 May;32(sup2):198-205. (PMID: 32172592)
Lancet. 2017 Jan 7;389(10064):91-102. (PMID: 27717615)
Psychol Methods. 2002 Jun;7(2):147-77. (PMID: 12090408)
Acta Psychiatr Scand. 1997 Jun;95(6):469-75. (PMID: 9242841)
Front Public Health. 2022 Aug 25;10:894546. (PMID: 36091559)
Front Public Health. 2022 Sep 23;10:977453. (PMID: 36249226)
Pilot Feasibility Stud. 2025 Feb 14;11(1):18. (PMID: 39953573)
Children (Basel). 2025 Jan 27;12(2):. (PMID: 40003243)
Lancet Glob Health. 2021 Apr;9(4):e489-e551. (PMID: 33607016)
J Health Popul Nutr. 2012 Dec;30(4):472-86. (PMID: 23304914)
Dev Med Child Neurol. 2018 May;60(5):480-489. (PMID: 29468662)
Int J Environ Res Public Health. 2019 Nov 13;16(22):. (PMID: 31766126)
BMJ Open. 2023 Jan 24;13(1):e062562. (PMID: 36693690)
Disabil Health J. 2018 Oct;11(4):495-501. (PMID: 30054226)
Front Public Health. 2023 Mar 14;11:1119851. (PMID: 36998276)
Front Public Health. 2024 Jun 19;12:1390107. (PMID: 38962774)
Dev Med Child Neurol. 2025 Jul;67(7):892-900. (PMID: 39731751)
BMJ Glob Health. 2023 Jan;8(1):. (PMID: 36650017)
BMC Med. 2024 Feb 2;22(1):51. (PMID: 38302917)
Invest Ophthalmol Vis Sci. 1985 Aug;26(8):1158-62. (PMID: 4019107)
Front Public Health. 2023 Feb 16;11:1122009. (PMID: 36891340)
J Stat Comput Simul. 2015;85(17):3498-3511. (PMID: 26379316)
J Affect Disord. 2014;167:358-67. (PMID: 25020271)
JAMA Netw Open. 2024 May 1;7(5):e2413550. (PMID: 38709738)
EClinicalMedicine. 2018 Dec;6:26-35. (PMID: 30740596)
Contributed Indexing: Keywords: Child Health; Children; Low and Middle Income Countries; Rehabilitation
Entry Date(s): Date Created: 20260919 Date Completed: 20260919 Latest Revision: 20260925
Update Code: 20260925
PubMed Central ID: PMC13599960
DOI: 10.1136/bmjpo-2025-004460
PMID: 42763110
Database: MEDLINE
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  Data: Validation of neurodevelopmental assessments for early detection of high-risk infants in Zimbabwe: protocol for the Child Development Observation study (ChiDO study).
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  Data: <searchLink fieldCode="AU" term="%22Mudawarima+L%22">Mudawarima L</searchLink>; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe.<br /><searchLink fieldCode="AU" term="%22Santos+N%22">Santos N</searchLink>; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Chimhini+GL%22">Chimhini GL</searchLink>; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe.<br /><searchLink fieldCode="AU" term="%22Mujuru+HA%22">Mujuru HA</searchLink>; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe.<br /><searchLink fieldCode="AU" term="%22Magonya+R%22">Magonya R</searchLink>; Department of Child, Adolescent and Women's Health, University of Zimbabwe Faculty of Medicine and Health Sciences, Harare, Harare Province, Zimbabwe.<br /><searchLink fieldCode="AU" term="%22Ghosh+R%22">Ghosh R</searchLink>; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California, USA.<br /><searchLink fieldCode="AU" term="%22Martin-Herz+SP%22">Martin-Herz SP</searchLink>; Institute for Global Health Sciences, University of California San Francisco, San Francisco, California, USA Susanne.MartinHerz@ucsf.edu.; Pediatrics, University of California San Francisco School of Medicine, San Francisco, California, USA.
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  Data: <searchLink fieldCode="JN" term="%22101715309%22">BMJ paediatrics open</searchLink> [BMJ Paediatr Open] 2026 Sep 19; Vol. 10 (1). <i>Date of Electronic Publication: </i>2026 Sep 19.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22BMJ+Publishing+Group%22">BMJ Publishing Group </searchLink><i>Country of Publication: </i>England <i>NLM ID: </i>101715309 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>2399-9772 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2223999772%22">23999772 </searchLink><i>NLM ISO Abbreviation: </i>BMJ Paediatr Open <i>Subsets: </i>MEDLINE
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  Data: <i>Original Publication</i>: London : BMJ Publishing Group, [2017]-
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  Data: <searchLink fieldCode="MM" term="%22Neurodevelopmental+Disorders%22">Neurodevelopmental Disorders*</searchLink>/<searchLink fieldCode="MM" term="%22Neurodevelopmental+Disorders+diagnosis%22">diagnosis</searchLink> <br /><searchLink fieldCode="MM" term="%22Neurodevelopmental+Disorders%22">Neurodevelopmental Disorders*</searchLink>/<searchLink fieldCode="MM" term="%22Neurodevelopmental+Disorders+etiology%22">etiology</searchLink> <br /><searchLink fieldCode="MM" term="%22Asphyxia+Neonatorum%22">Asphyxia Neonatorum*</searchLink>/<searchLink fieldCode="MM" term="%22Asphyxia+Neonatorum+complications%22">complications</searchLink> <br /><searchLink fieldCode="MM" term="%22Developmental+Disabilities%22">Developmental Disabilities*</searchLink>/<searchLink fieldCode="MM" term="%22Developmental+Disabilities+diagnosis%22">diagnosis</searchLink> <br /><searchLink fieldCode="MM" term="%22Child+Development%22">Child Development*</searchLink><br /><searchLink fieldCode="MH" term="%22Humans%22">Humans</searchLink> ; <searchLink fieldCode="MH" term="%22Zimbabwe%22">Zimbabwe</searchLink> ; <searchLink fieldCode="MH" term="%22Infant%22">Infant</searchLink> ; <searchLink fieldCode="MH" term="%22Prospective+Studies%22">Prospective Studies</searchLink> ; <searchLink fieldCode="MH" term="%22Longitudinal+Studies%22">Longitudinal Studies</searchLink> ; <searchLink fieldCode="MH" term="%22Early+Diagnosis%22">Early Diagnosis</searchLink> ; <searchLink fieldCode="MH" term="%22Female%22">Female</searchLink> ; <searchLink fieldCode="MH" term="%22Infant%2C+Newborn%22">Infant, Newborn</searchLink> ; <searchLink fieldCode="MH" term="%22Neurodevelopment%22">Neurodevelopment</searchLink> ; <searchLink fieldCode="MH" term="%22Male%22">Male</searchLink> ; <searchLink fieldCode="MH" term="%22Resource-Limited+Settings%22">Resource-Limited Settings</searchLink> ; <searchLink fieldCode="MH" term="%22Child%2C+Preschool%22">Child, Preschool</searchLink> ; <searchLink fieldCode="MH" term="%22Research+Design%22">Research Design</searchLink> ; <searchLink fieldCode="MH" term="%22Risk+Assessment%22">Risk Assessment</searchLink>
– Name: Abstract
  Label: Abstract
  Group: Ab
  Data: Introduction: Appropriate neurodevelopmental assessment tools are often unavailable in low- and middle-income countries (LMICs) due to lack of validation, cost and cultural-linguistic challenges. This reduces the availability of high-quality developmental evaluation, resulting in clinical gaps that impact individual child outcomes and modifiable risk detection for prevention. The objective of this study is to validate three neurodevelopmental assessment tools for early detection in low-resource settings through recruitment of infants across the neurodevelopmental impairment (NDI) risk spectrum related to perinatal asphyxia and neonatal encephalopathy (NE).<br />Methods: This prospective, longitudinal cohort study in Harare, Zimbabwe will collect data at 3 months, 6 months, 12 months, 18 months and 24 months. The sample of approximately 600 caregiver-infant dyads will include: (1) infants without clinical concern for perinatal asphyxia or other complications (low risk); (2) infants who do not cry at birth and require resuscitation but do not have NE (moderate risk) and (3) infants who experience NE (high risk). In addition to demographic, antenatal and perinatal data collected at enrolment, neurodevelopmental assessments to be conducted include the Prechtl General Movement Assessment (GMA); Hammersmith Infant Neurological Examination (HINE); Global Scales for Early Development (GSED); Mullen Scales of Early Learning (MSEL) and caregiver-reported Ages and Stages Questionnaire. At the 24-month visit, a comprehensive diagnostic evaluation for NDI will be conducted adhering to international guidance. Predictive ability of all tools will be assessed by receiver operating characteristic (ROC) analyses, including area under the ROC curve. Construct validity of the GSED will be assessed by comparing to the MSEL. The GSED's ability to differentiate subgroups defined by correlates of NDI risk will be assessed using generalised estimating equations.<br />Ethics and Dissemination: Ethical approvals have been obtained. If shown to be valid, the GMA and HINE could provide earlier, feasible and low-cost detection of children at elevated risk for NDI.<br /> (© World Health Organization 2026. Licensee BMJ.)
– Name: Abstract
  Label: Competing Interests
  Group: Ab
  Data: Competing interests: SPMH serves as a technical advisor for the World Health Organization Brain Health Unit which oversees and coordinates research and programming related to the Global Scales for Early Development. All other authors have no competing interest to declare.
– Name: Ref
  Label: References
  Group: RefInfo
  Data: Neonatology. 2018;114(4):341-347. (PMID: <searchLink fieldCode="PM" term="%2230130752%22">30130752)</searchLink><br />BMC Public Health. 2025 Feb 10;25(1):535. (PMID: <searchLink fieldCode="PM" term="%2239930359%22">39930359)</searchLink><br />J Clin Med. 2023 May 20;12(10):. (PMID: <searchLink fieldCode="PM" term="%2237240681%22">37240681)</searchLink><br />Cureus. 2025 Feb 7;17(2):e78719. (PMID: <searchLink fieldCode="PM" term="%2240065858%22">40065858)</searchLink><br />S Afr J Commun Disord. 2018 Mar 08;65(1):e1-e9. (PMID: <searchLink fieldCode="PM" term="%2229781700%22">29781700)</searchLink><br />Dev Med Child Neurol. 2024 Aug;66(8):990-1012. (PMID: <searchLink fieldCode="PM" term="%2238351549%22">38351549)</searchLink><br />BMJ Glob Health. 2025 Apr 02;10(4):. (PMID: <searchLink fieldCode="PM" term="%2240180429%22">40180429)</searchLink><br />Acta Paediatr. 1997 Jul;86(7):757-61. (PMID: <searchLink fieldCode="PM" term="%229240886%22">9240886)</searchLink><br />AIDS Care. 2020 May;32(sup2):198-205. (PMID: <searchLink fieldCode="PM" term="%2232172592%22">32172592)</searchLink><br />Lancet. 2017 Jan 7;389(10064):91-102. (PMID: <searchLink fieldCode="PM" term="%2227717615%22">27717615)</searchLink><br />Psychol Methods. 2002 Jun;7(2):147-77. (PMID: <searchLink fieldCode="PM" term="%2212090408%22">12090408)</searchLink><br />Acta Psychiatr Scand. 1997 Jun;95(6):469-75. (PMID: <searchLink fieldCode="PM" term="%229242841%22">9242841)</searchLink><br />Front Public Health. 2022 Aug 25;10:894546. (PMID: <searchLink fieldCode="PM" term="%2236091559%22">36091559)</searchLink><br />Front Public Health. 2022 Sep 23;10:977453. (PMID: <searchLink fieldCode="PM" term="%2236249226%22">36249226)</searchLink><br />Pilot Feasibility Stud. 2025 Feb 14;11(1):18. (PMID: <searchLink fieldCode="PM" term="%2239953573%22">39953573)</searchLink><br />Children (Basel). 2025 Jan 27;12(2):. (PMID: <searchLink fieldCode="PM" term="%2240003243%22">40003243)</searchLink><br />Lancet Glob Health. 2021 Apr;9(4):e489-e551. (PMID: <searchLink fieldCode="PM" term="%2233607016%22">33607016)</searchLink><br />J Health Popul Nutr. 2012 Dec;30(4):472-86. (PMID: <searchLink fieldCode="PM" term="%2223304914%22">23304914)</searchLink><br />Dev Med Child Neurol. 2018 May;60(5):480-489. (PMID: <searchLink fieldCode="PM" term="%2229468662%22">29468662)</searchLink><br />Int J Environ Res Public Health. 2019 Nov 13;16(22):. (PMID: <searchLink fieldCode="PM" term="%2231766126%22">31766126)</searchLink><br />BMJ Open. 2023 Jan 24;13(1):e062562. (PMID: <searchLink fieldCode="PM" term="%2236693690%22">36693690)</searchLink><br />Disabil Health J. 2018 Oct;11(4):495-501. (PMID: <searchLink fieldCode="PM" term="%2230054226%22">30054226)</searchLink><br />Front Public Health. 2023 Mar 14;11:1119851. (PMID: <searchLink fieldCode="PM" term="%2236998276%22">36998276)</searchLink><br />Front Public Health. 2024 Jun 19;12:1390107. (PMID: <searchLink fieldCode="PM" term="%2238962774%22">38962774)</searchLink><br />Dev Med Child Neurol. 2025 Jul;67(7):892-900. (PMID: <searchLink fieldCode="PM" term="%2239731751%22">39731751)</searchLink><br />BMJ Glob Health. 2023 Jan;8(1):. (PMID: <searchLink fieldCode="PM" term="%2236650017%22">36650017)</searchLink><br />BMC Med. 2024 Feb 2;22(1):51. (PMID: <searchLink fieldCode="PM" term="%2238302917%22">38302917)</searchLink><br />Invest Ophthalmol Vis Sci. 1985 Aug;26(8):1158-62. (PMID: <searchLink fieldCode="PM" term="%224019107%22">4019107)</searchLink><br />Front Public Health. 2023 Feb 16;11:1122009. (PMID: <searchLink fieldCode="PM" term="%2236891340%22">36891340)</searchLink><br />J Stat Comput Simul. 2015;85(17):3498-3511. (PMID: <searchLink fieldCode="PM" term="%2226379316%22">26379316)</searchLink><br />J Affect Disord. 2014;167:358-67. (PMID: <searchLink fieldCode="PM" term="%2225020271%22">25020271)</searchLink><br />JAMA Netw Open. 2024 May 1;7(5):e2413550. (PMID: <searchLink fieldCode="PM" term="%2238709738%22">38709738)</searchLink><br />EClinicalMedicine. 2018 Dec;6:26-35. (PMID: <searchLink fieldCode="PM" term="%2230740596%22">30740596)</searchLink>
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