Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02800109 |
| Other study ID # |
SMRU1504 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 2016 |
| Est. completion date |
February 2018 |
Study information
| Verified date |
February 2024 |
| Source |
University of Oxford |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to measure the impact of maternal malaria on child growth in the
two first years of life in relation to fetal growth.
This study is following a birth cohort of children born to pregnant women enrolled in the
study "Impact of malaria infection in pregnancy on fetal and newborn growth" (protocol OXTREC
14 08 and Mahidol 2009-003-01). In this cohort growth monitoring is conducted until 2 years
of age using routine anthropometric measurements such as weight, length, arm and head
circumference. A few additional tests will enhance the sensitivity of the study outcomes with
minimal risk. These tests will include anthropometry, screening, nutrition questionnaire and
neurodevelopmental assessment.
This study was funded by Wellcome Trust core funding, grant ref. number Wellcome Trust Major
Overseas Program Grant no. 220211 (2020-2025)
Description:
This is an existing on-going prospective birth cohort of children born to the pregnant women
who had fetal growth assessed during pregnancy. In this cohort an expected 10% of pregnant
women will be exposed to malaria while the remaining will be free of malaria. Their offspring
are already followed up for growth monitoring from birth until 2 years of age with
anthropometric measurements including weight, length, arm and head circumference at each
scheduled visit. The investigator would like to enhance the sensitivity of the study outcomes
with minimal risk for the child by proposing the following anthropometric and screening
tests, nutrition questionnaire, and neurodevelopment assessment. In addition a prospective
cohort of children born after study approval will be followed on both protocols. The
additional measure include:
- Body fat composition (at birth, and monthly up to 4 months unless weight ≥ 8kg)
- Triceps and subscapular skinfold (at 1 and 2 years)
- Anemia, malaria and soil-transmitted helminths screening (every 3 months in first 12
months and 6-monthly 1-2 years)
- Buccal swab (at 1 and 2 years)
- Neurodevelopment (every 6 months)
- Food questionnaire (at 1 and 2 years)
Summary of results:
The beginning of the recruitment was delayed until the finalization and approval of the
translated PIS/ICF; from then on, the recruitment was smooth. Overall, 201 children from the
ongoing existing birth cohort were still present and eligible to participate in this part of
the study; 173 completed 2 years of FUP 28 were lost. Data and samples from these 173
children were included in the analysis of a large, multi-center, study, the INTERBIO-21st.
The pooled findings show 1. Cognitive development, language, and visual skills at 2 years of
age vary according to the trajectories of fetal cranial growth 2. There is a critical window
period at 20-25 weeks gestational age when fetal cranial trajectories may diverge and when
fetal abdominal circumference growth may accelerate or decelerate 3. Preterm newborn's growth
and neurocognitive development vary according to their birth phenotype characteristics (i.e.
those classified in the "birth infections" phenotype were at higher risk for poor scoring in
fine and gross motor development compared to term newborns) 4. An indication of a greater
increase in weight in proportion to height during the 2 first years of life if there was a
faltering growth phenotype observed during gestation.
Maternal malaria and anemia's role in the development of children were evaluated specifically
for this study site and included all the children followed up to one year of age. Preliminary
results show that 48% of children are stunted at 2 years of age and that malaria and anemia
independently are significant contributors to the decline in growth z-scores during infancy
(manuscript in preparation); that 66% of children have anemia (HCT<33%) in the first year of
life, the median age for a first HCT<33% is 4 months of age and that moderate, but not mild
anemia in infancy reduces the median neurodevelopment score at year of age. Maternal anemia
but not malaria is a factor contributing to increased risk of anemia in infants. Results were
presented at local and regional and international conferences and were part of a MSc thesis.
