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. 2022 Jan;6(1):e001327.
doi: 10.1136/bmjpo-2021-001327.

Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study: protocol of a pragmatic clinical effectiveness study to improve birth outcomes in Ethiopia

Anne Cc Lee  1   2 , Firehiwot Workneh Abate  3 , Luke C Mullany  4 , Estifanos Baye  5   2 , Yoseph Yemane Berhane  3 , Mulatu Melese Derebe  6 , Michelle Eglovitch  5 , Nebiyou Fasil  3 , Ingrid E Olson  5 , Workagegnehu Tarekegn Kidane  3 , Tigest Shiferaw  3 , Fisseha Shiferie  3 , Fitsum Tsegaye  3 , Sitota Tsegaye  3 , Kalkidan Yibeltal  3 , Grace J Chan  2   7   8 , Parul Christian  4 , Sheila Isanaka  9 , Yunhee Kang  4 , Chunling Lu  2   10 , Mandefro M Mengistie  11 , Rose L Molina  2   12 , Michele D Stojanov  12 , Fred Van Dyk  4 , Amare Worku Tadesse  3   13 , Asresie T Wondale  14 , Blair J Wylie  2   12 , Alemayehu Worku  3 , Yemane Berhane  15
Affiliations

Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study: protocol of a pragmatic clinical effectiveness study to improve birth outcomes in Ethiopia

Anne Cc Lee et al. BMJ Paediatr Open. 2022 Jan.

Abstract

Introduction: The WHO Nutrition Target aims to reduce the global prevalence of low birth weight by 30% by the year 2025. The Enhancing Nutrition and Antenatal Infection Treatment (ENAT) study will test the impact of packages of pregnancy interventions to enhance maternal nutrition and infection management on birth outcomes in rural Ethiopia.

Methods and analysis: ENAT is a pragmatic, open-label, 2×2 factorial, randomised clinical effectiveness study implemented in 12 rural health centres in Amhara, Ethiopia. Eligible pregnant women presenting at antenatal care (ANC) visits at <24 weeks gestation are enrolled (n=2400). ANC quality is strengthened across all centres. Health centres are randomised to receive an enhanced nutrition package (ENP) or standard nutrition care, and within each health centre, individual women are randomised to receive an enhanced infection management package (EIMP) or standard infection care. At ENP centres, women receive a regular supply of adequately iodised salt and iron-folate (IFA), enhanced nutrition counselling and those with mid-upper arm circumference of <23 cm receive a micronutrient fortified balanced energy protein supplement (corn soya blend) until delivery. In standard nutrition centres, women receive routine counselling and IFA. EIMP women have additional screening/treatment for urinary and sexual/reproductive tract infections and intensive deworming. Non-EIMP women are managed syndromically per Ministry of Health Guidelines. Participants are followed until 1-month post partum, and a subset until 6 months. The primary study outcomes are newborn weight and length measured at <72 hours of age. Secondary outcomes include preterm birth, low birth weight and stillbirth rates; newborn head circumference; infant weight and length for age z-scores at birth; maternal anaemia; and weight gain during pregnancy.

Ethics and dissemination: ENAT is approved by the Institutional Review Boards of Addis Continental Institute of Public Health (001-A1-2019) and Mass General Brigham (2018P002479). Results will be disseminated to local and international stakeholders.

Registration number: ISRCTN15116516.

Keywords: growth; neonatology.

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Conflict of interest statement

Competing interests: ACCL reports funding from the Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development and the WHO. YB reports funding from FORMAS, USAID, National Institute of Environmental Health Sciences and from the Bill & Melinda Gates Foundation. BJW reports funding from National Institute of Environmental Health Sciences and from the Bill & Melinda Gates Foundation.

Figures

Figure 1
Figure 1
Conceptual diagram showing the pathways that link maternal undernutrition, maternal infection and infant outcomes.
Figure 2
Figure 2
Enhancing Nutrition and Antenatal Infection Treatment study consort diagram. BEP, balanced protein-energy; EIMP, enhanced infection management package; ENP, enhanced nutrition package; GA, gestational age; IFA, iron–folate; MUAC, mid-upper arm circumferences; RTI, reproductive tract infection; STI, sexually transmitted infection; UTI, urinary tract infection.
Figure 3
Figure 3
Enhancing Nutrition and Antenatal Infection Treatment study site map, Amhara region, Ethiopia. ENP, enhanced nutrition package.
See this image and copyright information in PMC

References

    1. World Health Organization . Global nutrition targets 2025: low birth weight policy brief. Geneva, Switzerland, 2014.
    1. Blencowe H, Krasevec J, de Onis M, et al. . National, regional, and worldwide estimates of low birthweight in 2015, with trends from 2000: a systematic analysis. Lancet Glob Health 2019;7:e849–60. 10.1016/S2214-109X(18)30565-5 - DOI - PMC - PubMed
    1. Katz J, Lee AC, Kozuki N, et al. . Mortality risk in preterm and small-for-gestational-age infants in low-income and middle-income countries: a pooled country analysis. Lancet 2013;382:417–25. 10.1016/S0140-6736(13)60993-9 - DOI - PMC - PubMed
    1. Christian P, Lee SE, Donahue Angel M, et al. . Risk of childhood undernutrition related to small-for-gestational age and preterm birth in low- and middle-income countries. Int J Epidemiol 2013;42:1340–55. 10.1093/ije/dyt109 - DOI - PMC - PubMed
    1. Blencowe H, Lee ACC, Cousens S, et al. . Preterm birth-associated neurodevelopmental impairment estimates at regional and global levels for 2010. Pediatr Res 2013;74 Suppl 1:17–34. 10.1038/pr.2013.204 - DOI - PMC - PubMed

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