Project Details

Offspring neurodevelopment after maternal preconception nutrition supplement: Evaluating a new tool

Nancy Krebs, MD, MS

Summary

BACKGROUND: The absence of a multi-dimensional neurodevelopmental assessment tool suitable for populations in low resource settings that is easy and rapid to administer in the field limits comparability among studies of nutrition and early child development. Also lacking are large cohorts in low resource settings for whom detailed information is available regarding potential risks and protective factors for early child development. GAP: The gap in availability of a multi-dimensional assessment tool for early childhood development will be addressed by testing the “INTERGROWTH-21st Neurodevelopment Package” (INTER-NDA) in 2 year olds from 4 low-middle income countries (Democratic Republic of the Congo, Guatemala, India, Pakistan) whose mothers participated in the “Women First” (WF) trial, an RCT nutrition intervention initiated prior to conception and through pregnancy (Arm 1) vs the same intervention initiated in 2nd trimester (Arm 2) vs a non-intervention control group (Arm 3). HYPOTHESES: • H-1: Scores on the cognition domain of the INTER-NDA for the offspring of women in Arm 1 (pre-conception + prenatal) will be significantly higher than those for offspring of women in Arm 2 (prenatal), or than the offspring of women in Arm 3 (control). • H-2: Independent of group, length for age Z-score (LAZ) and change in LAZ between 6 and 24 months will be correlated with scores for cognition on INTER-NDA. • H-3: Cognitive scores from INTER-NDA and the Bayley Scales of Infant Development (BSID-III) tests will exhibit similarly strong associations to LAZ and/or ΔLAZ, and the ratio of the slopes of these relationships will be similar to that of existing direct comparisons of INTER-NDA and BSID-III cognitive scores. METHODS: This project provides a cross-sectional comparison of INTER-NDA results among three arms for the WF offspring. Testing was conducted in a randomly selected subgroup at each of 4 sites, representing 1/3 of children/arm; BSID-III was administered in 2/3 of children in each arm. Longitudinal growth and anthropometric measurements were obtained in all subjects. In addition to primary outcome of cognitive domain for comparison to BSID-III, the INTER-NDA includes assessment of vision; auditory function; and language, behavior, motor skills and attention, all of which will be compared among arms. Subjects were 24 month old offspring of mothers who completed the WF trial through the 6 mo post-partum) and whose growth was measured at 12, 18 and 24 months of age. RESULTS: Complete usable data for INTER-NDA were available for 88.2% of the original sample. For the visual acuity and contrast tests (Cardiff test), data were available for 86.8 and 78.2%, respectively, of the sample. The proportions of participating subjects from each of the 4 sites were similar, ranging from 20.0 -28.5%, and from the 3 arms, ranging from 32.4-34.3%. No significant differences were found in any of the domains of INTER-NDA or the vision testing among the 3 intervention arms (Hypothesis 1). Cognitive scores were associated with length at 24 months (p < 0.001). Length at 24 months was associated with all INTER-NDA and vision outcomes except with fine motor scores (Hypothesis 2). Comparisons between the INTER-NDA and BSID-III test results are still pending (as of July 2020). IMPACT: The results of this study have demonstrated the feasibility of a simple, less expensive tool to holistically assess neurodevelopment in young children in LMIC. As additional analyses are completed, including comparison with the commonly used BSID-III tests, results will inform the potential utility of the INTER-NDA as an assessment tool to evaluate the burden of impaired early childhood development and evaluating the impact of interventions.