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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
  1. Linda Vesel1,
  2. Lauren Spigel1,
  3. Jnanindra Nath Behera2,
  4. Roopa M Bellad3,
  5. Leena Das2,
  6. Sangappa Dhaded3,
  7. Shivaprasad S Goudar3,
  8. Gowdar Guruprasad4,
  9. Sujata Misra2,
  10. Sanghamitra Panda5,
  11. Latha G Shamanur6,
  12. Sunil S Vernekar3,
  13. Irving F Hoffman7,
  14. Tisungane Mvalo8,9,
  15. Melda Phiri8,
  16. Friday Saidi8,
  17. Rodrick Kisenge10,
  18. Karim Manji10,
  19. Nahya Salim10,
  20. Sarah Somji10,
  21. Christopher R Sudfeld11,
  22. Linda Adair12,
  23. Bethany A Caruso13,
  24. Christopher Duggan14,
  25. Kiersten Israel-Ballard15,
  26. Anne CC Lee16,
  27. Stephanie L Martin12,
  28. Kimberly L Mansen15,
  29. Krysten North16,
  30. Melissa Young13,
  31. Emily Benotti1,
  32. Megan Marx Delaney1,
  33. Eliza Fishman1,
  34. Katelyn Fleming1,
  35. Natalie Henrich1,
  36. Kate Miller1,
  37. Laura Subramanian1,
  38. Danielle E Tuller1,
  39. Katherine EA Semrau1,17
  1. 1Ariadne Labs, Harvard T.H. Chan School of Public Health / Brigham and Women's Hospital, Boston, Massachusetts, USA
  2. 2Department of Paediatrics, SCB Medical College and Hospital, Cuttack, Orissa, India
  3. 3Jawaharlal Nehru Medical College, KLE Academy of Higher Education and Research, Belgaum, Karnataka, India
  4. 4Department of Neonatology, JJM Medical College, Davangere, Karnataka, India
  5. 5Department of Obstetrics and Gynaecology, City Hospital, Cuttack, Orissa, India
  6. 6Department of Paediatrics, SS Institute of Medical Sciences and Research Center, Davangere, Karnataka, India
  7. 7Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA
  8. 8Department of Pediatrics, University of North Carolina Project Malawi, Lilongwe, Malawi
  9. 9Department of Pediatrics, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA
  10. 10Department of Pediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania
  11. 11Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA
  12. 12Department of Nutrition, University of North Carolina at Chapel Hill Gillings School of Global Public Health, Chapel Hill, North Carolina, USA
  13. 13Hubert Department of Global Health, Emory University School of Public Health, Atlanta, Georgia, USA
  14. 14Center for Nutrition, Boston Children's Hospital, Boston, Massachusetts, USA
  15. 15Maternal, Newborn, Child Health and Nutrition Program, PATH, Seattle, Washington, USA
  16. 16Department of Pediatric Newborn Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
  17. 17Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to Dr Linda Vesel; lvesel{at}ariadnelabs.org

Abstract

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.

  • epidemiology
  • neonatology
  • nutrition & dietetics
  • public health
  • qualitative research
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Footnotes

  • Twitter @DrFridaySaidi, @k_semrau

  • 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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