Bahir Dar Child Development Study, Ethiopia

NCT06648863 | Completed

• 1 other identifier: 2022P002539
• Study Type: observational
• Target: 471
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about typical neurodevelopment in children aged 6 months to 5 years who live in Bahir Dar, Ethiopia. The main aims of the study are: Aim 1: To characterize typical neurodevelopment as measured by i) brain volume using low-field MRI and ii) scores on behavioral assessments of early child neurodevelopment. Aim 2: To characterize typical pre-academic school skills in early childhood as measured by tasks of visual processing, reasoning, verbal expression and school readiness. Aim 3: To identify factors influencing child development in a community in Bahir Dar, Amhara region of Ethiopia, as measured by validated measures of maternal mental health, home environment, and childhood adversity. Participants will complete one low-field MRI scan at enrollment, have a hemoglobin blood test, and undergo age-appropriate neurodevelopmental assessments and surveys that may include:

• WHO Global Scales for Early Development (GSED) \[ages 6 - 36 months\]
• Tasks of visual reasoning and verbal expression \[ages 48-60 months\]
• Executive Functions test using the tablet-based NIH Toolbox \[ages 48-60 months\]
• School Readiness questionnaire assessing knowledge of literacy, numeracy, early reading, crystallized knowledge, memory, and self-regulation \[ages 48-60 months\]
• Maternal report of child's motor, cognitive and socioemotional skillsChild Anthropometrics assessment Additional assessments of the participant's family and environment will include
• Medical History questionnaire
• Family socioeconomic status
• Maternal Mental Health
• Recent Life Events and hardship
• Home Environment and Parenting UNICEF's MICs Family Care Indicators)
• Food security and feeding practices

Conditions

Development, Child; Behavior, Social

Keywords

Neurodevelopment; Africa; Cross-sectional

Outcome Measures

Primary Outcomes (1)

• Total Brain MRI volumes

  Total supratentorial brain volume measured from Hyperfine MRI uzing standard processing pipelines for infant MRI progressing. Outcomes will be reported in cm3.

  Collected in all children (ages 6-60 months) at enrollment.

Secondary Outcomes (8)

• WHO Global Scales for Early Development (GSED)

  Collected in children aged 6-36 months at enrollment.

• Visual reasoning

  Collected in children aged 48-60 months at enrollment.

• School readiness

  Collected in children aged 48-60 months at enrollment.

• Executive Functioning: cognitive flexibility and attention

  Collected in children aged 48-60 months at enrollment.

• Self-regulation

  Collected in children aged 48-60 months at enrollment.

Study Arms (8)

A/6 months

Measures of child development (GSED), nutrition, medical history and anthropometrics, followed by MRI

B/12 months

Measures of child development (GSED), nutrition, medical history and anthropometrics, followed by MRI

C/18 months

Measures of child development (GSED), nutrition, medical history and anthropometrics, followed by MRI

D/24 months

Measures of child development (GSED), nutrition, medical history and anthropometrics, followed by MRI

E/30 months

Measures of child development (GSED), nutrition, medical history and anthropometrics, followed by MRI

F/36 months

Measures of child development (GSED), nutrition, medical history and anthropometrics, followed by MRI

G/48 months

Measures of child neurocognitive development and school readiness, nutrition, medical history, and anthropometrics followed by MRI

H/60 months

Measures of child neurocognitive development and school readiness, nutrition, medical history, and anthropometrics followed by MRI

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children will be identified at rural health centers, outpatient vaccination clinics or campaigns, and other health facilities around Bahir Dar, Amhara, Ethiopia.

You may qualify if:

• Children living in Bahir Dar town with parents who are willing and able to travel to Felege Hiwot Regional Hospital clinic for study visits
• Healthy child without active clinical symptoms/complaints
• Child within specified age ranges for each cohort/group (+/- 2 months)

You may not qualify if:

• Child born with a severe congenital birth defect or hypoxic ischemic encephalopathy (birth asphyxia) per maternal report
• Severe developmental or behavioral disorder per maternal report
• Severe illness/clinical signs or symptoms of illness based on maternal and child report (including vomiting, headache, or seizures)
• Plans to move out of catchment area in less than 1 year

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Addis Continental Institute of Public Health: collaborator
• New York University: collaborator
• Boston Children's Hospital, Boston, MA, USA: collaborator

Study Sites (1)

Health Center

Bahir Dar, Addis, Ethiopia

Location

Related Publications (1)

• Jensen SKG, Yibeltal K, North K, Workneh F, Teklehaimanot A, Abate BH, Fasil N, Melka TL, Chin TI, Folger LV, Roy Paladhi U, Van Dyk F, Thomason ME, Grant PE, Inder T, Worku A, Berhane Y, Lee AC. Bahir Dar Child Development Cross-Sectional Study, Ethiopia: study protocol. BMJ Paediatr Open. 2025 Apr 2;9(1):e003173. doi: 10.1136/bmjpo-2024-003173.

  PMID: 40180427 DERIVED

MeSH Terms

Conditions

Social Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Anne C Lee, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Yemane Berhane, MD, PhD

  Addis Continental Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Global Newborn Health

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 18, 2024
• Study Start: April 29, 2024
• Primary Completion: November 11, 2024
• Study Completion: December 1, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

ET (1)