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

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

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.

Keywords: epidemiology; neonatology; nutrition & dietetics; public health; qualitative research.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Data collection timeline by activity and infant age.
Figure 2
Figure 2
Margin of error in estimation of a single proportion with a sample of 300 at each study site for the prospective observational cohort.

References

    1. United Nations - SDG . Goal 3: ensure healthy lives and promote well-being for all at all ages — SDG indicators, 2017.
    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
    1. Liu L, Oza S, Hogan D, et al. . Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the sustainable development goals. Lancet 2016;388:3027–35. 10.1016/S0140-6736(16)31593-8
    1. Imdad A, Bhutta ZA. Nutritional management of the low birth weight/preterm infant in community settings: a perspective from the developing world. J Pediatr 2013;162:S107–14. 10.1016/j.jpeds.2012.11.060
    1. Blencowe H, Cousens S, Oestergaard MZ, et al. . National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet 2012;379:2162–72. 10.1016/S0140-6736(12)60820-4
    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
    1. Lee ACC, Katz J, Blencowe H, et al. . National and regional estimates of term and preterm babies born small for gestational age in 138 low-income and middle-income countries in 2010. Lancet Glob Health 2013;1:e26–36. 10.1016/S2214-109X(13)70006-8
    1. Mwaniki MK, Atieno M, Lawn JE, et al. . Long-term neurodevelopmental outcomes after intrauterine and neonatal insults: a systematic review. Lancet 2012;379:445–52. 10.1016/S0140-6736(11)61577-8
    1. Lawn JE, Kerber K, Enweronu-Laryea C, et al. . 3.6 million neonatal deaths--what is progressing and what is not? Semin Perinatol 2010;34:371–86. 10.1053/j.semperi.2010.09.011
    1. Pawar SJ, Oleti T, Bharathi S, et al. . Growth and neurodevelopmental outcome in preterm LBW infants with sepsis in India: a prospective cohort. Int J Pediatr 2018;2018:1–9. 10.1155/2018/5735632
    1. Upadhyay RP, Martines JC, Taneja S, et al. . Risk of postneonatal mortality, hospitalisation and suboptimal breast feeding practices in low birthweight infants from rural Haryana, India: findings from a secondary data analysis. BMJ Open 2018;8:e020384. 10.1136/bmjopen-2017-020384
    1. Rana R, McGrath M, Gupta P, et al. . Feeding interventions for infants with growth failure in the first six months of life: a systematic review. Nutrients 2020;12. 10.3390/nu12072044. [Epub ahead of print: 09 Jul 2020].
    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
    1. Lawn JE, Kerber K, Enweronu-Laryea C, et al. . Newborn survival in low resource settings--are we delivering? BJOG 2009;116 Suppl 1:49–59. 10.1111/j.1471-0528.2009.02328.x
    1. Blanc AK, Wardlaw T. Monitoring low birth weight: an evaluation of international estimates and an updated estimation procedure. Bull World Health Organ 2005;83:178–85.
    1. Gisore P, Shipala E, Otieno K, et al. . Community based weighing of newborns and use of mobile phones by village elders in rural settings in Kenya: a decentralised approach to health care provision. BMC Pregnancy Childbirth 2012;12:15. 10.1186/1471-2393-12-15
    1. World Health Organization, United Nations Children’s Fund (UNICEF) . Low birthweight: country, regional and global estimate World Health Organization; 2004.
    1. North K, Marx Delaney M, Bose C, et al. . The effect of milk type and fortification on the growth of low-birthweight infants: an umbrella review of systematic reviews and meta-analyses. Matern Child Nutr 2021;17:e13176. 10.1111/mcn.13176
    1. World Health Organization . Guidelines on optimal feeding of low birth-weight infants in low- and middle-income countries. Geneva, 2011.
    1. Brown S, McSharry P. Improving accuracy and usability of growth charts: case study in Rwanda. BMJ Open 2016;6:e009046. 10.1136/bmjopen-2015-009046
    1. Urgent call for an investigation into the feeding of sick & vulnerable newborns | by JustACTIONS | Medium [Internet]. Available: [Accessed 24 Jun 2021].
    1. WHO . Survive and thrive: transforming care for every small and sick newborn. Geneva, Switzerland: World Health Organization, 2018.
    1. Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. BMJ 2007;335.
    1. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care 2007;19:349–57. 10.1093/intqhc/mzm042
    1. Creswell JW, Vicki L, Clark P. Designing and conducting mixed methods research. 3rd ed, 2017.
    1. Villar J, Giuliani F, Bhutta ZA, et al. . Postnatal growth standards for preterm infants: the Preterm Postnatal Follow-up Study of the INTERGROWTH-21(st) Project. Lancet Glob Health 2015;3:e681–91. 10.1016/S2214-109X(15)00163-1
    1. Villar J, Cheikh Ismail L, Victora CG, et al. . International standards for newborn weight, length, and head circumference by gestational age and sex: the newborn cross-sectional study of the INTERGROWTH-21st project. Lancet 2014;384:857–68. 10.1016/S0140-6736(14)60932-6
    1. de Onis M, Onyango AW, Borghi E, et al. . Comparison of the world Health organization (who) child growth standards and the National center for health Statistics/WHO international growth reference: implications for child health programmes. Public Health Nutr 2006;9:942–7. 10.1017/PHN20062005
    1. Noel-Weiss J, Courant G, Woodend AK. Physiological weight loss in the breastfed neonate: a systematic review. Open Med 2008;2:e99–110.
    1. Macdonald PD, Ross SRM, Grant L, et al. . Neonatal weight loss in breast and formula fed infants. Arch Dis Child Fetal Neonatal Ed 2003;88:472F–6. 10.1136/fn.88.6.F472
    1. DiTomasso D, Cloud M. Systematic review of expected weight changes after birth for full-term, breastfed newborns. J Obstet Gynecol Neonatal Nurs 2019;48:593–603. 10.1016/j.jogn.2019.09.004
    1. Fenton TR, Anderson D, Groh-Wargo S, et al. . An attempt to standardize the calculation of growth velocity of preterm Infants-Evaluation of practical bedside methods. J Pediatr 2018;196:77–83. 10.1016/j.jpeds.2017.10.005
    1. Homan GJ. Failure to thrive: a practical guide. Am Fam Physician 2016;94:295–9.
    1. McCoy DC, Sudfeld CR, Bellinger DC, et al. . Development and validation of an early childhood development scale for use in low-resourced settings. Popul Health Metr 2017;15:3. 10.1186/s12963-017-0122-8
    1. Kroenke K, Spitzer RL, Williams JBW. The patient health Questionnaire-2: validity of a two-item depression screener. Med Care 2003;41:1284–92. 10.1097/01.MLR.0000093487.78664.3C
    1. Hennink MM, Kaiser BN, Marconi VC. Code saturation versus meaning saturation: how many interviews are enough? Qual Health Res 2017;27:591–608. 10.1177/1049732316665344
    1. Dimagi . CommCare. Cambridge, MA: Dimagi, 2021.
    1. StataCorp LLC . Stata statistical software. College Station, TX: StataCorp LLC, 2019.
    1. SAS Institute . Sas software suite. Cary, NC: SAS Institute, 2020.
    1. Gale RC, Wu J, Erhardt T, et al. . Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans health administration. Implement Sci 2019;14:11. 10.1186/s13012-019-0853-y
    1. Taylor B, Henshall C, Kenyon S, et al. . Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? a mixed methods study comparing rapid and thematic analysis. BMJ Open 2018;8:e019993. 10.1136/bmjopen-2017-019993
    1. Gale NK, Heath G, Cameron E, et al. . Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol 2013;13:117. 10.1186/1471-2288-13-117
    1. Harvard Dataverse [Internet]. Available: [Accessed 24 Jun 2021].
    1. O'Leary M, Edmond K, Floyd S, et al. . A cohort study of low birth weight and health outcomes in the first year of life, Ghana. Bull World Health Organ 2017;95:574–83. 10.2471/BLT.16.180273
    1. Mahumud RA, Sultana M, Sarker AR. Distribution and determinants of low birth weight in developing countries. J Prev Med Public Health 2017;50:18–28. 10.3961/jpmph.16.087
    1. Marete I, Ekhaguere O, Bann CM, et al. . Regional trends in birth weight in low- and middle-income countries 2013-2018. Reprod Health 2020;17:176. 10.1186/s12978-020-01026-2
    1. IIPS . National family health survey 2015-2016. Mumbai: International Institute for Population Sciences, 2017.
    1. Countdown Country Profiles [Internet]. Countdown to 2030. Available: [Accessed 30 Oct 2020].
    1. IGME . IGME UN Inter-agency Group for Child Mortality Estimation [Internet], 2020. Available: [Accessed 07 Dec 2020].
    1. Sarnat HB, Sarnat MS. Neonatal encephalopathy following fetal distress. A clinical and electroencephalographic study. Arch Neurol 1976;33:696–705. 10.1001/archneur.1976.00500100030012
    1. Roland EH, Hill A. Clinical aspects of perinatal hypoxic-ischemic brain injury. Semin Pediatr Neurol 1995;2:57–71. 10.1016/S1071-9091(05)80005-1
    1. Clopton N. The Dubowitz assessment of gestational age. Phys Occup Ther Pediatr 1983;3:75–86. 10.1080/J006v03n03_08
    1. Dubowitz LM, Dubowitz V, Goldberg C. Clinical assessment of gestational age in the newborn infant. J Pediatr 1970;77:1–10. 10.1016/S0022-3476(70)80038-5
    1. Topp CW, Østergaard SD, Søndergaard S, et al. . The WHO-5 well-being index: a systematic review of the literature. Psychother Psychosom 2015;84:167–76. 10.1159/000376585
    1. Indicators for assessing infant and young child feeding practices: definitions and measurement methods. Geneva: World Health Organization and the United Nations Children’s Fund (UNICEF). Licence: CC BYNC-SA 3.0 IGO, 2021. Available: [Accessed 11 Nov 2021].
    1. Jensen D, Wallace S, Kelsay P. LATCH: a breastfeeding charting system and documentation tool. J Obstet Gynecol Neonatal Nurs 1994;23:27–32. 10.1111/j.1552-6909.1994.tb01847.x
    1. Hedberg Nyqvist K, Ewald U. Infant and maternal factors in the development of breastfeeding behaviour and breastfeeding outcome in preterm infants. Acta Paediatr 1999;88:1194–203. 10.1111/j.1651-2227.1999.tb01017.x
    1. Pados BF, Estrem HH, Thoyre SM, et al. . The neonatal eating assessment tool: development and content validation. Neonatal Netw 2017;36:359–67. 10.1891/0730-0832.36.6.359
    1. Manea L, Gilbody S, Hewitt C, et al. . Identifying depression with the PHQ-2: a diagnostic meta-analysis. J Affect Disord 2016;203:382–95. 10.1016/j.jad.2016.06.003

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