Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06296238 |
| Other study ID # |
2023P000461 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 15, 2023 |
| Est. completion date |
February 2025 |
Study information
| Verified date |
February 2024 |
| Source |
Brigham and Women's Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
In low-resource settings, undernutrition and infections during the first 1000 days of life
are prevalent, modifiable risk factors that may have lifelong effects on a child's cognitive
and psychological development, yet effective interventions addressing prevailing mechanisms
are still to be validated. Iron, protein and energy are critical nutrients that support the
rapidly developing fetal brain, however, among women of reproductive age in Sub-Saharan
Africa, 10% are underweight and 20% have iron deficiency anemia. Pregnancy infections are
also common in Africa, where one in three women have a geo-helminthic infection resulting in
blood loss, iron deficiency and inflammation. The interaction between iron and inflammation
in pregnancy is particularly complex. NICHD has identified the complex relationship between
nutrition, inflammation, and neurodevelopment as a major research gap. A barrier to progress
is that mechanistic understanding of prenatal brain development is based on animal or
observational studies. We present a unique opportunity to leverage an ongoing randomized
controlled trial (RCT) to examine the consequences of pregnancy nutrition and inflammation on
child neurodevelopment.
The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) RCT enrolled pregnant women
in Amhara, Ethiopia to study independent and overlapping effects of prenatal nutrition and
infection interventions on birth outcomes. Women were randomized to receive: 1) standard
prenatal care, 2) enhanced nutrition package (ENP) (counseling, iron-folic acid [IFA],
iodized salt, and balanced energy protein [BEP] supplementation), 3) enhanced infection
management package (EIMP) (anti-helminthics, urinary tract infection treatment), or 4)
ENP+EIMP. The current follow-up study (Longitudinal Infant Development and Growth; LIDG) will
investigate biological pathways by which ENAT interventions, specifically iron,
protein-energy, and inflammation, influence child neurodevelopment.
Our overarching hypotheses are that improving prenatal nutrition will improve brain
structural and network development, reducing inflammation will improve white matter
maturation, and the combination will have synergistic effects on child neuro-cognitive
outcomes. This study will follow up to 500 ENAT children to assess neurodevelopment through
24 months of age, including neurobehavior and neural networks.
