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. 2025 Nov 6;26(1):474.
doi: 10.1186/s13063-025-09034-y.

Nutritional management of growth faltering in infants aged under six months in Asia and Africa: study protocol for a multicentre randomised trial (BRANCH, BReAstfeediNg Counselling and management of growtH)

WHO BRANCH study group
Collaborators

Nutritional management of growth faltering in infants aged under six months in Asia and Africa: study protocol for a multicentre randomised trial (BRANCH, BReAstfeediNg Counselling and management of growtH)

WHO BRANCH study group. Trials. .

Abstract

Background: Treatment of growth faltering in early infancy may improve short and long term child health outcomes. The overall aim of this trial is to determine, in infants who meet study criteria for growth faltering, the effect of intensive breastfeeding counselling and support (IBFCS) plus nutritional milk supplementation (NMS) compared with IBFCS alone, on mortality, morbidity and growth at 6 completed months in low resource settings in South Asia and Sub-Saharan Africa. The primary outcome of the trial is wasting free survival (alive without wasting (weight for length standard deviation score < - 2 standard deviations (SD))) at 6 completed months of age.

Methods: This is a multi-centre, parallel-group, individually-randomized, non-blinded, controlled trial implemented in seven countries: three in Asia (Bangladesh, India and Pakistan) and four in Africa (Ethiopia, Nigeria, Tanzania and Uganda). Eleven thousand (11,000) infants with a gestational age of at least 28 weeks are enrolled and individually randomised between 7 and 14 days of age. The mother of each infant receives breastfeeding support from trained peer counsellors. Research workers follow up each infant 1-2 weekly at the infant's home to collect growth and outcome data. If infants meet study criteria for growth problems (slow weight gain, growth concern or growth faltering) they are reviewed by study clinicians, their medical problems are treated, and their mothers receive IBFCS. Infants with growth faltering in the intervention arm also receive nutritional milk supplementation (NMS) (prescribed quantities of term infant formula that meets Codex Alimentarius standards calculated to fulfill the needs for catch up growth). The comparison group receives IBFCS alone. Weekly growth monitoring continues and final outcome data (mortality, wasting) are measured in all infants at 6 completed months.

Discussion: This large randomised trial will provide evidence about the role of NMS, if any, in infants with growth faltering who do not respond to IBFCS and treatment of medical problems in low resource settings.

Trial registration: Australian and New Zealand Clinical Trial Registry (ANZCTR) CTRN12624000704594. Registered on June 4 2024.

Keywords: Breastfeeding; Growth; Infant; Malnutrition.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Approved 05/05/2025, WHO Ethics Review Committee (20, Avenue Appia,Ch-1211, Geneva 27, Switzerland; + 41 (0)22 791 1479; ercsec@who.int), ref:0003754). Written, informed consent to participate is obtained from all participants. The model consent form can be found in the Appendix 2. Name Name of incountry ethics committee Identification number World Health Organization World Health Organization Ethical review committee ERC.0003754 Bangladesh National Research Ethics Committee of Bangladesh Medical Research Council 486 09 05 2022 Ethiopia Ethiopian National Research Ethics Review Committee 17/246/419/23 India National Ethics Committee Registry for Biomedical and Health Research (NECRBHR), Department of Health Research, Government of India EC/NEW/INST/2022/DL/0140 Nigeria National Health Research Ethics Committee, Nigeria NHREC/27/02/2009a Pakistan National Bioethics Committee Pakistan NBC-810 Tanzania Zanzibar Health Research Ethics Committee ZAHREC/04/PR/MARCH/2023/07 Uganda Uganda National Council for Science and Technology HS2766ES Consent for publication: The members of the WHO BRANCH study group consent to publication. Competing interests: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flow
Fig. 2
Fig. 2
Trial activity matrix (SPIRIT matrix)
Fig. 3
Fig. 3
Growth monitoring schema
See this image and copyright information in PMC

References

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    1. World Health Organization. WHO guideline on the prevention and management of wasting and nutritional oedema (acute malnutrition) in infants and children under 5 years. Geneva: World Health Organization; 2023. Licence: cc by-nc-sa 3.0 igo. https://www.who.int/publications/i/item/9789240082830. - PubMed
    1. National Institute for Health and Care Excellence. Faltering growth–recognition and management, 2017. https://www.nice.org.uk/guidance/ng75. Accessed 7 Sept 2025. - PubMed
    1. World Health Organization. WHO recommendations on maternal and newborn care for a positive postnatal experience. Geneva: World Health Organization; 2022. p. 242. - PubMed
    1. World Health Organization. WHO recommendations on newborn health: guidelines approved by the WHO Guidelines Review Committee. Geneva: World Health Organization; 2017. p. 26.

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