2025-02-12-世界卫生组织-BRANCH_Breastfeeding_counselling_and_management_of_growth_faltering_trial_3页_105kb

WHO BRANCH Trial Summary

Core Content

The WHO BRANCH Trial is a large-scale, multi-centre, individually randomised, non-blinded, controlled trial aimed at evaluating the effectiveness of intensive breastfeeding counselling and support (IBFCS) combined with nutritional milk supplementation (NMS) in preventing and managing growth faltering in infants under six months of age in low-resource settings across South Asia and Sub-Saharan Africa.

The trial seeks to determine whether the addition of NMS to IBFCS improves wasting-free survival, morbidity, and growth outcomes at six months of age. It also explores the impact of NMS on subgroup-specific outcomes based on birth weight and gestational age.

Main Objectives

• Primary Objective: Assess the effect of NMS on wasting-free survival (alive without wasting, defined as WFL z score < -2 sd) at 6 completed months.
• Secondary Objectives:
  1. Evaluate the impact of NMS on common childhood morbidities, underweight, wasting, and stunting.
  2. Analyze the effect of NMS on the primary outcome in subgroups defined by birth weight and gestational age (term AGA, preterm AGA, term SGA, preterm SGA).
  3. Optimize breastfeeding support for vulnerable newborns and infants with growth faltering.
  4. Develop operational guidance for breastfeeding and intensive lactation support in low and middle-income countries.

Trial Design

• Type: Multi-centre, parallel-group, individually-randomized, non-blinded, controlled trial.
• Countries Involved: Seven countries – Bangladesh, Ethiopia, India, Nigeria, Pakistan, Tanzania, and Uganda.
• Eligibility: Infants ≥28 weeks gestation.
• Enrollment: 11,000 infants are enrolled at 7 to <14 days of age.
• Intervention:
  • Intervention Group: IBFCS + NMS (term infant formula meeting Codex alimentarius standards for catch-up growth).
  • Comparator Group: IBFCS alone.
• Follow-up:
  • 1-2 weekly home visits for growth and outcome data collection.
  • Final outcome assessment at 6 completed months of age, including mortality and wasting.

Key Considerations

• Programmatic Implications:
  • Exclusive breastfeeding and responsive feeding remain the most important interventions for preventing and managing growth faltering.
  • Despite breastfeeding support, some infants may still experience growth faltering due to factors like chronic infections, insufficient stimulation, poor caregiving, and maternal health issues.
  • There are no WHO guidelines for early intervention of growth faltering in the first six months, making this study a critical step in addressing the gap.
  • It is unclear whether NMS provides additional benefits or poses risks such as infectious disease, contamination, unsafe water, and feed dilution in low-resource settings.
• Timeline: Infants are enrolled over 18 months and followed up until 6 months of age.
• Sponsor and Coordinator: The trial is coordinated and sponsored by the World Health Organization (WHO) Newborn and Child Health and Development Unit (NBC).
• External Funders: Bill and Melinda Gates Foundation.
• Trial Registration:
  • Australian and New Zealand Clinical Trial Registry (ANZ CTR): CTRN12624000704594.
  • WHO Ethical Review Committee (ERC): Number WHO ERC.0003754.
  • Statistical Analysis Plan: Available on request as WHO BRANCH-TCU.

Principal Investigators

Conclusion

The WHO BRANCH Trial is designed to address a significant gap in early childhood nutrition and growth management in low-resource regions. By evaluating the role of NMS in conjunction with IBFCS, the study aims to provide evidence-based guidance for improving infant health outcomes and supporting existing health systems.