Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package: Implementation Research

NCT06390943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 632

Last updated 2026-02-23

No results posted yet for this study

Summary

Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP) aims to improve feeding and growth outcomes among low birthweight (LBW; \<2.5kg) or preterm (\<37 weeks gestational age) infants admitted to neonatal intensive care units (NICU) in India, Malawi, and Tanzania by (1) supporting the initiation, establishment, and maintenance of maternal lactation and prioritized provision of human milk, Kangaroo Mother Care (KMC) and appropriate water, sanitation and hygiene (WASH) practices; and (2) facilitating feeding counseling at home post-discharge from the facility.

Conditions

Interventions

OTHER

Facility-based feeding support package plus (FB-FSP+)

Package of materials to support facility-based feeding and lactation, KMC and WASH, including a training curriculum, training guide, and implementation materials, such as Standard Operating Procedures (SOPs) and job aides

OTHER

Transition-to-home feeding support package plus (TTH-FSP+)

Package of materials to support transition-to-home feeding and lactation, KMC and WASH, including a training curriculum, training guide, and implementation materials, such as Standard Operating Procedures (SOPs) and job aides

Sponsors & Collaborators

  • Boston Children's Hospital

    collaborator OTHER
  • Community Empowerment Lab

    collaborator OTHER
  • Emory University

    collaborator OTHER
  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER
  • Jawaharlal Nehru Medical College

    collaborator OTHER
  • PATH

    collaborator OTHER
  • University of North Carolina

    collaborator OTHER
  • Brigham and Women's Hospital

    collaborator OTHER
  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Katherine Semrau, PhD, MPH · Ariadne Labs

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Minute
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-08
Primary Completion
2026-02-13
Completion
2026-02-13

Countries

  • India
  • Malawi
  • Tanzania

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06390943 on ClinicalTrials.gov