Suchergebnisse

OBJECTIVES: Newborn size, including length, has been associated with later growth. Preconception nutrition supplementation in Women First (WF) trial (clinicaltrials.gov NCT01883193) was associated with higher newborn length and lower rates of stunting. The objective was to examine postnatal growth outcomes through 6 mo in the WF offspring. METHODS: Subjects were 2450 infants from the WF sites in Democratic Republic of Congo (DRC), Guatemala, India, and Pakistan with the 3 WF arms maintained: Arm 1 started a lipid-based nutrition supplement ≥ 3 mo prior to conception; Arm 2 started same supplement at ∼11 wk gestation; and Arm 3 received no trial supplements. Maternal supplementation was discontinued at delivery. Anthropometric measurements were obtained at birth, 0.5, 1, 3, and 6 mo; Z-scores were calculated from WHO Child Growth Standards. Primary and secondary outcomes were analyzed using longitudinal generalized estimating equations accounting for the correlation of repeated measures over time and study cluster. Intervention effects were evaluated within each site as well as overall, adjusting for site and baseline maternal covariates that differed by arm. Statistical interaction between arm and infant sex was evaluated and included if significant. RESULTS: Longitudinal growth (length and weight) curves from 0–6 mo demonstrated differences by intervention arm, with Arms 1 and 2 more favorable compared to Arm 3 (Table + LAZ in Figure). Relative risks (RR) for stunting were significantly lower for Arms 1 and 2 (vs. Arm 3) (Table). Site-specific analyses revealed some site differences warranting further exploration. CONCLUSIONS: Without any postnatal intervention, differences in fetal growth evident at birth persisted at 6 months. FUNDING SOURCES: Bill & Melinda Gates Foundation; NIH, NICHD & ODS. SUPPORTING TABLES, IMAGES AND/OR GRAPHS:

OBJECTIVE: To evaluate whether the fetal linear growth effects of maternal nutrition supplementation would be maintained through 6 months postnatal age. STUDY DESIGN: The Women First trial was a multicountry, individually randomized clinical trial that compared the impact of maternal nutrition supplementation-initiated preconception (Arm 1) vs at ~11 weeks of gestation (Arm 2), vs no supplement (Arm 3); the intervention was discontinued at delivery. Trial sites were Democratic Republic of Congo, Guatemala, India, and Pakistan. Analysis includes 2421 infants born to 2408 randomized women. Primary outcome was the trajectory of length-for-age z scores (LAZ) by arm, based on assessments at birth and 1, 3, and 6 months. We fitted longitudinal models on growth from birth to 6 months using generalized estimating equations; maternal intervention effects were evaluated, adjusting for site and baseline maternal covariates. RESULTS: Linear growth for Arms 1 and 2 was statistically greater than for Arm 3 in 3 of the 4 countries, with average pairwise mean differences in LAZ of 0.25 (95% CI 0.15–0.35; P < .001) and 0.19 (95% CI 0.09–0.28; P < .001), respectively. Compared with Arm 3, average overall adjusted relative risks (95% CI) for stunting (LAZ <–2) were lower for Arms 1 and 2: 0.76 (0.66–0.87; P < .001) and 0.77 (0.67–0.88; P < .001), respectively. CONCLUSIONS: Improved linear growth in early infancy observed for the 2 intervention arms supports the critical importance of maternal nutrition before conception and in the early phase of gestation. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01883193.