Nutrition and Inflammation in Pregnancy: Impacts on Early Human Brain Development in Ethiopia

Summary

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.

Conditions

• Prenatal Exposure Delayed Effects

Sponsors & Collaborators

• Addis Continental Institute of Public Health

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• New York University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Brown University

  lead OTHER

Principal Investigators

• Yemane Berhane · Addis Continental Institute of Public Health

• Anne CC Lee · Warren Alpert Medical School of Brown University

Eligibility

Min Age

9 Months

Max Age

27 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-15

Primary Completion

2024-07-01

Completion

2024-07-01

Countries

• Ethiopia

Study Locations