Broad Goal: To participate in all collaborative activities relevant to the mission of the Global Network including the development and leadership of Common Network projects as exemplified by Preconception Maternal Nutrition. Study Objective: Determine the public health benefits in resource-poor populations of providing a comprehensive nutrition supplement to women of reproductive age commencing S3 mo. prior to conception (Arm 1, PC) in comparison with starting the same supplement at 12 wk. gestation (Arm 2, PG) or provision of iron/folate alone (Arm 3, IPS). Primary outcomes: (1) length-for-age Z-score (LAZ) at 7 d postpartum; (2) LAZ at 6 mo. of age. Secondary outcomes include: comparing arms for fetal length; birth weight; incidence of low birth weight; incidence of perinata and early infancy (<6 mo.) mortality and severe infectious disease morbidity. Research Design & Methods: Multi-site randomized controlled efficacy trial. Each arm will include 800 women divided equally among sites. The first 100 of each arm in each site to conceive continue interventions <6 mo. postpartum. Inclusion criteria: para 1-2, <26 yr., enrolled through Global Network Maternal Neonatal Health Registry (MNHR); algorithms based on MNHR data to enroll at 12 3 mo. post-partum. Arm 1 commences intervention at enrollment; Arms 2 and 3 receive IPS from enrollment with Arm 2 switching to same supplement as Arm 1 at 12 weeks gestation. Intervention provides 100 kcal/d as a lipid-based multi-micronutrient (MMN) product, with increasing energy to 500 kcal/d and protein to 25g/d if BMI <20 or pregnancy weight gain is low. Baseline parental, fetal (ultrasound), birth weight, early neonatal (7 d) and infant anthropometry (3 and 6 mo.); longitudinal maternal blood, subsample cord blood & placenta samples will be collected by trained Network and Health personnel. Mortality and morbidity data will be collected from MNHR. The primary analyses will compare LAZ at 7 days for Arm 1 vs. Arms 2 and 3 controlling for site. The results of this study have potentially profound implications for the impat of nutrition interventions initiated prior to conception, and for the reversibility of adverse intergenerational effects, including linear growth failure.

Public Health Relevance

Pre- and postnatal growth is associated with greater morbidity and mortality and with long-term loss of human capital. Nutrition interventions during pregnancy or infancy in resource-poor populations are only partially successful in decreasing growth failure. This proposal tests the hypothesis that benefits to offspring of maternal nutrition interventions are greatly enhanced when commenced prior to conception.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
4U10HD076474-04
Application #
9063436
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Raju, Tonse N
Project Start
2013-07-01
Project End
2018-04-30
Budget Start
2016-05-01
Budget End
2017-04-30
Support Year
4
Fiscal Year
2016
Total Cost
Indirect Cost
Name
University of Colorado Denver
Department
Pediatrics
Type
Schools of Medicine
DUNS #
041096314
City
Aurora
State
CO
Country
United States
Zip Code
80045
Pasha, O; McClure, E M; Saleem, S et al. (2018) A prospective cause of death classification system for maternal deaths in low and middle-income countries: results from the Global Network Maternal Newborn Health Registry. BJOG 125:1137-1143
McClure, E M; Garces, A; Saleem, S et al. (2018) Global Network for Women's and Children's Health Research: probable causes of stillbirth in low- and middle-income countries using a prospectively defined classification system. BJOG 125:131-138
Harrison, Margo S; Saleem, Sarah; Ali, Sumera et al. (2018) A Prospective, Population-Based Study of Trends in Operative Vaginal Delivery Compared to Cesarean Delivery Rates in Low- and Middle-Income Countries, 2010-2016. Am J Perinatol :
Duffy, Cassandra R; Moore, Janet L; Saleem, Sarah et al. (2018) Malpresentation in low- and middle-income countries: Associations with perinatal and maternal outcomes in the Global Network. Acta Obstet Gynecol Scand :
Goldenberg, Robert L; Saleem, Sarah; Ali, Sumera et al. (2017) Maternal near miss in low-resource areas. Int J Gynaecol Obstet 138:347-355
Hambidge, K Michael; Krebs, Nancy F; Garcés, Ana et al. (2017) Anthropometric indices for non-pregnant women of childbearing age differ widely among four low-middle income populations. BMC Public Health 18:45
Harrison, Margo S; Pasha, Omrana; Saleem, Sarah et al. (2017) A prospective study of maternal, fetal and neonatal outcomes in the setting of cesarean section in low- and middle-income countries. Acta Obstet Gynecol Scand 96:410-420
Garces, Ana L; McClure, Elizabeth M; Pérez, Wilton et al. (2017) The Global Network Neonatal Cause of Death algorithm for low-resource settings. Acta Paediatr 106:904-911
Chomba, Elwyn; Carlo, Wally A; Goudar, Shivaprasad S et al. (2017) Effects of Essential Newborn Care Training on Fresh Stillbirths and Early Neonatal Deaths by Maternal Education. Neonatology 111:61-67
Garces, Ana; McClure, Elizabeth M; Figueroa, Lester et al. (2016) A multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth: a case study from the Guatemalan Western Highlands. Reprod Health 13:63

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