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Nutritional management of growth faltering in infants aged under six months in Asia and Africa

Nutritional management of growth faltering in infants aged under six months in Asia and Africa. An individually randomised trial - Breastfeeding Counselling and Management of Growth in early infancy (BRANCH)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043716
Enrollment
11000
Registered
2022-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Breastfeeding promotion and support
Lactation management
Clinical management: WHO Breastfeeding Counselling Guidelines on breastfeeding promotion and support will be used
Advanced WHO breastfeeding management guidelines will be used for lactation management (expression of breastmilk, feeding of expressed breast milk by cup or paladai, scheduling of feeding, management
WHO Pocket Book Clinical Management Guidelines will be used for clinical management Intervention2: Breastfeeding promotion and support: WHO Breastfeeding Counselling Guidelines on breastfeeding promot
WHO Pocket Book Clinical Management

Sponsors

Dr Nita Bhandari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Ultrasound based gestational age before 20 weeks of gestation is available - Baby is 28 weeks gestation or more - Birth weight taken within 72 hours after birth - Baby has been fed breastmilk anytime since birth

Exclusion criteria

Exclusion criteria: -The biological mother is dead at the time of screening -Baby has a major abnormality or condition which is impairing feeding or nutrition (such as severe cleft palate, severe asphyxia, severe respiratory distress syndrome, need for mechanical ventilation, severe necrotising enterocolitis, major surgery) -Family does not intend to live in the study area for six months -The mother has given birth to three or more babies (ie twins are included but triplets or quadruplets etc are excluded) -A baby from the same household is currently a part of the study (i.e is being visited by the study team).

Design outcomes

Primary

MeasureTime frame
Wasting free survival; infant alive at six months and not wasted (weight for length z score less than -2 SD)Timepoint: Infant age 6 months

Secondary

MeasureTime frame
Mortality: all-cause mortalityTimepoint: Infant age 6 months;Underweight: weight-for-age z score less than -2 SDTimepoint: Infant age 6 months;Wasting: weight-for-length z score less than -2 SDTimepoint: Infant age 6 months;Severe wasting: weight-for-length z score less than -3 SDTimepoint: Infant age 6 months;Stunting: length-for-age z score less than -2 SDTimepoint: Infant age 6 months;Concurrent wasting and stuntingTimepoint: Infant age 6 months;All-cause morbidity: hospitalization in previous 2 weeks for any causeTimepoint: Infant age 6 months;Cause-specific morbidity: hospitalization in previous 2 weeks for diarrhoea, pneumonia, other infectious disease, other causeTimepoint: Infant age 6 months;Exclusive breastfeedingTimepoint: Infant age 6 months;Process evaluation activities will cover different components in the following areas: breastfeeding promotion, lactation support, use of breastmilk substitutes, social aspects (parenting self-efficacy, social well-being) & costing for family (out-of-pocket expenditure) & health system costsTimepoint: Throughout the study period

Countries

India

Contacts

Public ContactDr Sunita Taneja

Centre for Health Research and Development, Society for Applied Studies

sunita.taneja@sas.org.in01146043751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026