Observational study on child development in Bahir Dar, Ethiopia
Bahir Dar Child Development Study, Ethiopia
Brigham and Women's Hospital · NCT06648863
This study looks at how children aged 6 months to 5 years in Bahir Dar, Ethiopia, develop their brains and skills, while also checking how things like their mom's mental health and their surroundings affect their growth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 6 Months to 60 Months |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Locations | 1 site (Bahir Dar, Addis) |
| Trial ID | NCT06648863 on ClinicalTrials.gov |
What this trial studies
This observational study aims to understand typical neurodevelopment in children aged 6 months to 5 years living in Bahir Dar, Ethiopia. It will assess brain volume using low-field MRI and evaluate behavioral assessments related to early child neurodevelopment. Additionally, the study will explore pre-academic skills and identify factors influencing child development, including maternal mental health and environmental conditions. Participants will undergo MRI scans, blood tests, and various neurodevelopmental assessments.
Who should consider this trial
Good fit: Ideal candidates are healthy children aged 6 months to 5 years living in Bahir Dar with parents willing to participate.
Not a fit: Children with severe congenital defects, developmental disorders, or significant illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved interventions for enhancing child development in low-resource settings.
How similar studies have performed: While there is a gap in understanding neurodevelopment in low- and middle-income countries, similar studies in other regions have shown promising results in identifying developmental patterns.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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
Where this trial is running
Bahir Dar, Addis
- Health Center — Bahir Dar, Addis, Ethiopia (RECRUITING)
Study contacts
- Principal investigator: Anne C Lee, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Sarah Jensen, PhD
- Email: sarah.jensen@childrens.harvard.edu
- Phone: +1 617 8909196
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Development, Child, Behavior, Social