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

NCT06390943 | Completed

• 1 other identifier: IRB23-0273
• Study Type: interventional
• Target: 632
• Locations: 3 countries
• Sites: 5

Brief 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

Low Birthweight; Preterm Birth

Keywords

Lactation support; Kangaroo Mother Care; WASH

Outcome Measures

Primary Outcomes (6)

• Obj 1: Early initiation of mother's breast milk feeding

  % infants initiated breast milk feeding within 1 hour of birth

  1 hour after birth

• Obj 1: Early initiation of mother's first breast stimulation

  % mothers initiated breast stimulation via first breast milk expression or baby first put to breast within 1 hour of birth

  1 hour after birth

• Obj 1: Number of sessions when infant was fed mother's direct or expressed breast milk in previous 24 hours

  Mean number of mother's breast milk feeding sessions (direct or expressed) in the last 24 hours

  24 hours

• Obj 1: Number of mother's breast milk expression sessions in previous 24 hours

  Mean number of sessions in which mother expressed breast milk in the last 24 hours

  24 hours

• Obj 1 & 2: Maternal breastfeeding self-efficacy/confidence

  Mean score (range 14-70) on validated Breastfeeding Self-Efficacy Scale-Short Form; higher scores reflect more significant levels of breastfeeding self-efficacy

  Obj 1 Pilot: On day of facility discharge or at 2 weeks age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation; Obj 2: On day of enrollment and 2 weeks and 6 weeks later

• Obj 2: Growth velocity (g/kg/d)

  Mean change in infant's weight (growth) calculated in grams/kilogram/day (g/kg/ day) from facility discharge to study discharge

  6 weeks after initial facility discharge

Secondary Outcomes (9)

• Obj 1: Time of first feed of mother's breast milk in NICU

  From date/time of enrollment until date/time of first documented feed on mother's breast milk in the NICU, assessed up to facility discharge or 14 days, whichever comes first

• Obj 1: Growth velocity (g/kg/d)

  Obj 1 Pilot: Birth to day of discharge or 2 weeks of age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation

• Obj 1: 20g/kg/day weight gain

  Obj 1 Pilot: Birth to facility discharge or 2 weeks of age; Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation

• Obj 1 & 2: Infants fed exclusively on mother's own milk in the previous 24 hours

  24 hours

• Obj 1 & 2: Infants receiving KMC in previous 24 hours

  24 hours

Other Outcomes (2)

• Obj 1 & 2: % infants who receive the "minimum package"

  Obj 1 Pilot: At discharge or at 2 weeks age (whichever is first); Obj 1 Implementation: 1.5, 5.5 and 10.5 months after the start of study implementation; Obj 2: On day of enrollment and 2 weeks and 6 weeks later

• Obj 1: Feeding competency

  Difference between enrollment (within 24 hours of birth) and day of discharge or 2 weeks of age (whichever is first)

Study Arms (1)

Obj 1 Infants receiving facility-based FSP+; Obj 2 infants receiving transition-to-home FSP+

OTHER

Other: Facility-based feeding support package plus (FB-FSP+); Other: Transition-to-home feeding support package plus (TTH-FSP+)

Interventions

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

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

Obj 1 Infants receiving facility-based FSP+; Obj 2 infants receiving transition-to-home FSP+

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

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

Obj 1 Infants receiving facility-based FSP+; Obj 2 infants receiving transition-to-home FSP+

Eligibility Criteria

• Age: 1 Minute+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Infants
• Low birthweight (≤2.5kg) or preterm (\<37 weeks) infants admitted to NICU at study facility
• In-born infants admitted to the NICU within 24 hours of birth)
• Mother and infant alive during screening
• Mother consents for herself and infant
• Women (mothers) who are age of majority: Tanzania and India: 18+; Malawi: 16-17 and married OR 18+
• Healthcare providers
• Healthcare provider who was trained to deliver the facility-based FSP+
• Healthcare provider consents for him/herself

You may not qualify if:

• Infants
• Out-born infants referred to study facility NICU
• Congenital anomalies or acquired conditions that interfere with feeding or placement of nasogastric/ orogastric (NG/OG) tube \[e.g., cleft lip/palate, toxoplasmosis,other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, Congenital cardiac defect, neural tube defect, gastrointestinal (GI) tract anomalies, hydrocephalus, necrotizing enterocolitis\]
• Severe birth asphyxia
• Unknown date of birth and unknown gestational age
• OBJECTIVE 2 (TRANSITION-TO-HOME)
• Infants
• Infants in India-Uttar Pradesh site
• Lives within catchment areas of study facility (50km)
• Mother intends to stay in the catchment areas for 3 months post-birth with infant
• Community providers
• Community provider who was trained to deliver the transition-to-home FSP+.
• Community provider consents for him/herself
• Infants
• Not screened and was not exposed to objective 1 intervention (and meet all eligibility criteria)

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• PATH: collaborator
• Boston Children's Hospital: collaborator
• Community Empowerment Lab: collaborator
• Emory University: collaborator
• Muhimbili University of Health and Allied Sciences: collaborator
• Jawaharlal Nehru Medical College: collaborator
• University of North Carolina: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (5)

Ganesh Shankar Vidyarthi Memorial Medical College

Kanpur, India

Location

King George Medical College

Lucknow, India

Location

Institute of Medical Sciences, Banaras Hindu University

Varanasi, India

Location

Bwaila District Hospital

Lilongwe, Malawi

Location

Amana Regional Hospital

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Katherine Semrau, PhD, MPH

  Ariadne Labs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Ariadne Labs & Director, BetterBirth Program

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 30, 2024
• Study Start: May 8, 2024
• Primary Completion: February 13, 2026
• Study Completion: February 13, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TA (1); MA (1); IN (3)