Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol

Author:

Vesel LindaORCID,Spigel Lauren,Behera Jnanindra Nath,Bellad Roopa M,Das Leena,Dhaded Sangappa,Goudar Shivaprasad S,Guruprasad Gowdar,Misra Sujata,Panda Sanghamitra,Shamanur Latha G,Vernekar Sunil S,Hoffman Irving F,Mvalo Tisungane,Phiri Melda,Saidi FridayORCID,Kisenge Rodrick,Manji Karim,Salim Nahya,Somji Sarah,Sudfeld Christopher R,Adair Linda,Caruso Bethany A,Duggan Christopher,Israel-Ballard Kiersten,Lee Anne CCORCID,Martin Stephanie L,Mansen Kimberly L,North KrystenORCID,Young Melissa,Benotti Emily,Marx Delaney Megan,Fishman Eliza,Fleming Katelyn,Henrich Natalie,Miller Kate,Subramanian Laura,Tuller Danielle E,Semrau Katherine EAORCID

Abstract

IntroductionEnding preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, <2.5 kg) infants. The majority of LBW infants are born in low- and middle-income countries (LMICs) and account for more than 60%–80% of newborn deaths. Feeding promotion tailored to meet the nutritional needs of LBW infants in LMICs may serve a crucial role in curbing newborn mortality rates and promoting growth. The Low Birthweight Infant Feeding Exploration (LIFE) study aims to establish foundational knowledge regarding optimal feeding options for LBW infants in low-resource settings throughout infancy.Methods and analysisLIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants.Ethics and disseminationThis study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities.Trial registration numbersNCT04002908 and CTRI/2019/02/017475.

Funder

Bill and Melinda Gates Foundation

Publisher

BMJ

Subject

General Medicine

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