protocolSection identificationModule nctId: NCT06296238, orgStudyIdInfo id: 2023P000461, briefTitle: Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Brigham and Women's Hospital, class: OTHER, collaborators name: Addis Continental Institute of Public Health, collaborators name: Boston Children's Hospital, collaborators name: New York University, descriptionModule briefSummary: The goal of this observational child follow-up study is to examine the effects of prenatal nutrition and infection management interventions on long-term child neurodevelopment.Participants are the offspring of mothers in the main study entitled "Enhancing Nutrition and Antenatal Infection Treatment (ENAT)" that was conducted in the rural Amhara region of Ethiopia. In the ENAT pragmatic clinical effectiveness study, 2399 pregnant women were randomized to receive routine prenatal care, a package of enhanced nutrition interventions (balanced energy protein supplement, iodized salt, iron-folic acid and counseling), a package of enhanced infection management interventions (genitourinary tract infection screening-treatment, deworming), or a combination of both packages. The impact of these antenatal nutrition and infection interventions on birth outcomes (infant birth size and gestational length) was examined in the main study. In this longitudinal cohort study, we will follow the offspring from the ENAT pregnancy cohort up to 24 months postnatal age and assess their growth, health and neurodevelopment.The main questions it aims to answer are:1. What are the effects of pregnancy interventions from the parent study (ENAT) on offspring neurodevelopmental outcomes?2. What are the associations between maternal-newborn iron status and inflammation on infant neurodevelopment?3. What are the associations between maternal iodine status and thyroid function on infant neurodevelopment?We will follow children of mothers from the parent ENAT study to monitor their growth, health, and neurodevelopment up to 24 months postnatal age., conditionsModule conditions: Prenatal Exposure Delayed Effects, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Visual Evoked Potential (VEP) P1 Latency, secondaryOutcomes measure: EEG Functional Connectivity, secondaryOutcomes measure: Cecile Attention Task, secondaryOutcomes measure: Infant Head Circumference, secondaryOutcomes measure: Bayley III, Cognition, secondaryOutcomes measure: MAAP - Accuracy and Speed, secondaryOutcomes measure: Hammersmith Infant Neurological Exam (HINE), eligibilityModule sex: ALL, minimumAge: 9 Months, maximumAge: 27 Months, stdAges: CHILD, contactsLocationsModule locations facility: Harvard Medical School, city: Boston, state: Massachusetts, zip: 02115, country: United States, geoPoint lat: 42.35843, lon: -71.05977, locations facility: Addis Continental Institute of Public Health, city: Addis Ababa, country: Ethiopia, geoPoint lat: 9.02497, lon: 38.74689, hasResults: False