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Nutritional Management of Growth Faltering in Infants Aged Under Six Months in Asia and Africa (BRANCH Study)

The BRANCH study aims to identify the most effective approach to feeding infants under six months who experience growth faltering—a common concern in many parts of Asia and Africa. This study explores whether providing nutritional supplementation alongside intensive breastfeeding support leads to better growth outcomes compared to breastfeeding support alone.

By understanding the most effective interventions, this research contributes to improved nutritional strategies for vulnerable infants, potentially reducing infant morbidity and mortality across resource-limited settings.

Study Design

This is a multi-centre, parallel arm, individually randomized, non-blinded, controlled study implemented in seven countries: three in Asia (Bangladesh, India, and Pakistan) and four in Africa (Ethiopia, Nigeria, Tanzania, and Uganda).

Aims and Objectives

Aim

The overall aim of this study is to determine the effect of nutritional supplementation plus intensive breastfeeding support compared with intensive breastfeeding support alone on mortality, morbidity, and growth in infants aged 0-6 months with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.

Primary Objective

To determine the effect of nutritional supplementation on wasting free survival at 6 months of age.

Secondary Objectives

To determine the effect of nutritional supplementation on common childhood morbidities, underweight, wasting, and stunting outcomes.
To determine the effect of nutritional supplementation on the primary outcome in subgroups based on birth weight and gestational age at birth (term appropriate for gestational age [AGA], preterm AGA, term small for gestational age [SGA], preterm SGA).
To optimize breastfeeding support for vulnerable newborns and infants with growth faltering in low resource settings in South Asia and Sub-Saharan Africa.
To develop operational guidance on breastfeeding and intensive lactation support that can be used across low and middle income countries.

Africa

Countries involved in Africa: Ethiopia, Nigeria, Tanzania, and Uganda.

Asia

Countries involved in Asia: Bangladesh, India, and Pakistan.

Outcomes and Definitions

The primary and secondary outcomes will be assessed when the infant reaches 6 months of age.

Primary Outcome

Wasting Free Survival: A composite outcome of all-cause mortality or wasting.

Secondary Outcomes

Mortality: All cause mortality.
Underweight: Weight-for-age z-score < -2 standard deviations.
Wasting: Weight-for-length z-score < -2 standard deviations.
Severe Wasting: Weight-for-length z-score < -3 standard deviations.
Stunting: Length-for-age z-score < -2 standard deviations.
Concurrent Wasting and Stunting: A composite measure of wasting and/or stunting.
All-cause Morbidity: Hospitalisation in the previous 2 weeks for any cause.
Cause-specific Morbidity: Hospitalisation in the previous 2 weeks for diarrhoea, pneumonia, other infectious disease, or other causes.
Exclusive Breastfeeding: The infant receives only breast milk (directly, expressed, or from a wet nurse) until 6 months of age, with the exception of ORS, drops, and syrups (such as vitamins, minerals, and medicines).