Introduction Ending 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 analysis LIFE 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 dissemination This 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 numbers NCT04002908 and CTRI/2019/02/017475.
- nutrition & dietetics
- public health
- qualitative research
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Contributors Study conceptualisation and design was completed by ACCL, BAC, CD, CRS, DET, EB, IFH, KEAS, KI-B, KLM, KMa, KMi, KN, LA, LSp, LSu, LV, MY, NH, RMB, SD, SSG and TM. Protocol development and tool design was carried out by ACCL, BAC, CRS, DET, EB, EF, GG, IFH, JNB, KEAS, KF, KI-B, KLM, KMa, KMi, KN, LA, LD, LGS, LSp, LSu, LV, MY, MMD, NH, NS, RK, RMB, SLM, SM, SP, SMD, SSG, SS, SSV and TM. Tool pilot testing/modification were conducted by EB, EF, FS, GG, JNB, KF, LD, LGS, LSp, LSu, LV, MP, NH, NS, SM, SP, SS and SSV. Writing of the manuscript was conducted by LSp and LV. All authors reviewed multiple drafts of the manuscript and approved the final version.
Funding This work was supported, in whole or in part, by the Bill & Melinda Gates Foundation [OPP1192260]. Under the grant conditions of the Foundation, a Creative Commons Attribution 4.0 Generic License has already been assigned to the manuscript. The Bill & Melinda Gates Foundation reviewed the study design and sample-size calculations, but will not be involved in data collection, management, analysis, interpretation, writing of the manuscript, or the decision to submit manuscripts for publication.
Competing interests All authors completed the ICMJE conflict of interest form and were funded by the Bill & Melinda Gates Foundation for this work as part of the LIFE study. ACCL, BAC, CRS, DET, KEAS, KI-B, KLM, KMa, MMD, RK and SS have received funding from the Bill & Melinda Gates Foundation for maternal and newborn health work at large. CD reports other from American Society for Nutrition, other from UpToDate and other from People’s Medical Publishing House outside the submitted work. ACCL reports grants from the WHO and National Institute of Health NICHD outside the submitted work.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
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