According to research reviewed by Gram, a randomized controlled trial of 11,000 babies across seven countries in Asia and Africa is testing whether intensive breastfeeding support combined with extra infant formula helps malnourished newborns achieve wasting-free survival at 6 months better than breastfeeding support alone. Results are pending completion of the study.
Millions of babies in Africa and Asia aren’t growing properly in their first months of life, which can cause serious health problems. Researchers are testing whether giving babies extra infant formula, along with teaching mothers better breastfeeding techniques, helps these babies grow stronger and healthier. This massive study involves 11,000 babies across seven countries to find out if this combination approach works better than just teaching better breastfeeding alone. The results could change how doctors help struggling babies in areas with limited resources.
Key Statistics
A randomized controlled trial involving 11,000 newborn babies (at least 28 weeks gestation) from seven countries in South Asia and Sub-Saharan Africa is comparing intensive breastfeeding counseling plus infant formula supplementation versus breastfeeding support alone, with enrollment beginning in June 2024.
The study protocol, published in November 2024, measures ‘wasting-free survival’ as the primary outcome, tracking whether babies receiving formula supplementation plus breastfeeding support are more likely to survive without severe malnutrition (wasting) at 6 months compared to breastfeeding-only groups.
Research participants include babies from Bangladesh, India, Pakistan, Ethiopia, Nigeria, Tanzania, and Uganda, enrolled at 7-14 days old, with weekly home visits by research workers monitoring growth and health outcomes until 6 months of age.
The Quick Take
- What they studied: Whether giving babies extra infant formula plus breastfeeding support helps babies who aren’t growing properly survive and grow better compared to just breastfeeding support alone
- Who participated: 11,000 newborn babies (at least 28 weeks developed in the womb) from seven countries in Asia (Bangladesh, India, Pakistan) and Africa (Ethiopia, Nigeria, Tanzania, Uganda), enrolled when they were 7-14 days old
- Key finding: This is a study protocol describing how researchers will test whether the combination of intensive breastfeeding help plus extra infant formula helps babies with growth problems reach 6 months old without severe malnutrition
- What it means for you: If you live in a low-resource area and your baby isn’t gaining weight properly, this research may eventually show doctors a better way to help. However, results won’t be available until the study completes, so talk to your healthcare provider about current options
The Research Details
This is a large, carefully planned experiment called a randomized controlled trial. Researchers enrolled 11,000 babies across seven countries in South Asia and Sub-Saharan Africa. Each baby’s mother was randomly assigned to one of two groups—like flipping a coin to decide which treatment they’d receive. One group received intensive breastfeeding counseling and support from trained peer counselors (people from their community trained to help). The other group received the same breastfeeding support PLUS extra infant formula designed to help babies catch up on growth. All babies were monitored weekly at home by research workers who measured their growth and health. When babies showed signs of growth problems, study doctors examined them, treated any medical issues, and mothers in the formula group received extra milk supplementation while mothers in the other group received only breastfeeding support. The study tracked all babies until they reached 6 months old, measuring whether they survived and whether they avoided severe malnutrition.
This research design is important because it compares two realistic treatment approaches that could actually be used in poor communities. By randomly assigning babies to groups, researchers can fairly compare whether adding formula to breastfeeding support makes a real difference. The large number of babies (11,000) means the results will be reliable and apply to many different communities. Following babies at home weekly gives accurate growth measurements rather than relying on memory or occasional clinic visits.
This is a high-quality study design because: (1) It’s a randomized controlled trial, considered the gold standard for testing treatments; (2) It involves 11,000 babies, which is a large enough number to detect real differences; (3) It spans seven countries, making results more broadly applicable; (4) It uses trained peer counselors and standardized protocols to ensure consistent care; (5) It measures important real-world outcomes like survival and severe malnutrition rather than just lab numbers; (6) Weekly home visits provide accurate data collection. However, this is a study protocol (the plan), not yet the results, so we don’t yet know what the study found.
What the Results Show
This document describes the study plan rather than actual results. The main goal is to measure whether babies in the formula-plus-counseling group are more likely to survive without severe malnutrition (wasting) at 6 months compared to babies receiving only breastfeeding counseling. Researchers will measure ‘wasting-free survival,’ meaning babies who are alive and don’t have dangerous weight loss. The study also tracks secondary outcomes like overall growth, illness rates, and survival. Because this is a protocol paper published in November 2024 and the study was registered in June 2024, the actual results are not yet available. The study is currently enrolling babies and collecting data.
Beyond the main outcome, researchers will examine: how much weight babies gain, how many babies get sick and what illnesses they develop, how many babies die, and whether babies in the formula group grow faster than those with breastfeeding support alone. They’ll also look at whether the benefits differ between boys and girls, or between different countries. These secondary findings will help doctors understand not just whether formula helps, but how much it helps and for which babies it works best.
Previous research shows that babies who don’t grow properly in early infancy face serious risks including infections, developmental delays, and even death. Studies have shown that breastfeeding support helps some babies catch up on growth, but many babies still struggle despite good breastfeeding. This study tests whether adding formula to breastfeeding support helps more babies than breastfeeding alone. The research builds on smaller studies suggesting that combining approaches might work better than single treatments, but this large trial will provide stronger evidence.
Since this is a study protocol (the plan) rather than completed research, we cannot yet discuss actual limitations of the results. However, potential limitations of the study design include: (1) Mothers and doctors know which treatment babies receive (not blinded), which could influence how they care for babies; (2) Results may only apply to babies in these specific countries and may not work the same in other regions; (3) The study focuses on babies with specific growth problems, so results may not apply to all babies; (4) Factors like poverty, food availability, and water quality vary greatly between communities and could affect results.
The Bottom Line
This is a study protocol, so specific recommendations await the results. However, current evidence suggests: (1) Breastfeeding support from trained counselors helps babies grow better (moderate confidence); (2) Treating medical problems in babies with growth concerns is important (high confidence); (3) Whether adding formula helps beyond breastfeeding support is unknown and being tested (this study will provide evidence). Healthcare providers in low-resource settings should continue current best practices while awaiting these results.
Healthcare workers, public health officials, and policymakers in low-resource countries in Africa and Asia should pay attention to these results. Mothers of babies who aren’t gaining weight properly should discuss options with their healthcare provider. International health organizations focused on child nutrition should monitor this research. Parents in wealthy countries with good healthcare access may find this less directly relevant, though the science advances global child health knowledge.
This study began enrolling babies in mid-2024. Since babies are followed until 6 months old and data analysis takes time, results likely won’t be published until 2025 or 2026. Even after publication, it may take 1-2 years for health programs to implement new recommendations based on the findings. If you have a baby with growth concerns now, don’t wait for these results—talk to your healthcare provider about available options today.
Frequently Asked Questions
What is this study testing in babies with growth problems?
Researchers are testing whether combining intensive breastfeeding counseling with extra infant formula helps malnourished babies survive and grow better than breastfeeding support alone. The study involves 11,000 babies across seven countries in Asia and Africa.
How many babies are participating in this research?
The study includes 11,000 newborn babies at least 28 weeks developed in the womb from seven countries: Bangladesh, India, Pakistan, Ethiopia, Nigeria, Tanzania, and Uganda. Babies were enrolled at 7-14 days old.
When will the results of this study be available?
This is a study protocol published in November 2024 describing the research plan. The study is currently enrolling babies and collecting data, so actual results are not yet available. Completion timeline depends on ongoing enrollment and follow-up.
What makes this a high-quality research study?
It’s a randomized controlled trial with 11,000 babies across seven countries using trained peer counselors, standardized protocols, and weekly home visits for accurate measurements. This large, multi-country design ensures reliable results applicable to diverse communities.
Want to Apply This Research?
- Track your baby’s weight weekly and plot it on a growth chart. Record the date, baby’s weight in kilograms, and length in centimeters. Note any illnesses, feeding changes, or concerns. This creates a clear picture of whether your baby is gaining weight steadily or falling behind.
- If your baby shows slow weight gain, use the app to: (1) Schedule weekly weigh-ins at a health clinic or with a health worker; (2) Log breastfeeding sessions and any formula given; (3) Record any signs of illness; (4) Set reminders for counseling sessions with a breastfeeding supporter; (5) Share growth charts with your healthcare provider to discuss concerns early.
- Set up weekly weight tracking with alerts if weight gain drops below expected levels. Create a simple graph showing weight over time so you can visually see if your baby is catching up or falling further behind. Share this data with your healthcare provider at each visit. If your baby isn’t gaining weight despite good feeding, the app can help you communicate this clearly to doctors so they can investigate causes and adjust treatment.
This article describes a research study protocol, not completed results. The findings discussed are planned outcomes, not actual results. This information is for educational purposes only and should not replace medical advice from a qualified healthcare provider. If your baby is not gaining weight properly or shows signs of illness, consult a doctor immediately. Treatment decisions should be made in consultation with your healthcare provider based on your baby’s individual needs, local resources, and current medical guidelines. The effectiveness of the interventions described in this study has not yet been proven and is currently being tested.
This research translation is published by Gram Research, the science division of Gram, an AI-powered nutrition tracking app.