LIFT-UP: Randomized Controlled Trial of Fortification of Human Milk
NCT ID: NCT06765863
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
776 participants
INTERVENTIONAL
2025-01-16
2027-03-31
Brief Summary
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The primary research question is: Will VLBW or VPT infants in the NICU who are fed fortified human milk using a standardized feeding protocol have better growth outcomes by facility discharge and at 3 months of age, less illness by discharge, and decreased mortality by discharge and at one month compared to those who are not routinely fed fortified human milk using the same feeding protocol?
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Detailed Description
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OBJECTIVE: To evaluate (via individually randomized controlled study) the efficacy of feeding routinely and fortified human milk using a standardized clinical protocol to very LBW or very preterm infants in the NICU compared to not feeding routinely fortified human milk using the standardized clinical protocol.
STUDY DESIGN This study is a multi-site individually randomized prospective trial among VLBW or VPT infants admitted to the NICU in study facilities who consume human milk and meet eligibility criteria (along with their mothers).
SCREENING AND ENROLLMENT All infants admitted to the NICU and their mothers will be screened for study eligibility. Screening will be performed within 24 hours of birth for inborn infants and within 48 hours of birth for outborn infants. Eligible dyads with the intention to feed human milk \[mother's own milk (MOM) or pasteurized donor human milk (PDHM)\] whose mothers provide consent will be enrolled into the study.
Once the mother-infant dyad is enrolled and prior to randomization, they will:
Receive the guideline-driven standard of care and be provided access to breast pumps to help initiate and advance breast milk feeding. The guideline-driven standard of care includes facility-based lactation support/feeding counseling + KMC + WASH components designed specifically for small vulnerable newborns and was developed as part of a different study protocol (see NCT06390943).
Adhere to a clinical guideline including targets for initiating and advancing breast milk feeding. Initially, this clinical guideline will help infants achieve breast milk volume intake of at least 60 mL/kg/day, the primary criterion for randomization. After randomization, the clinical guideline will continue to support advancing human milk feeding for all infants advance to 180 mL/kg/day.
RANDOMIZATION Once an infant consumes at least 60 mL/kg/day of breast milk, enrolled dyads will be assessed for eligibility for randomization. Eligible dyads will be randomized individually in a 1:1 ratio to either the intervention or comparison arm. Randomization sequences will be previously generated by the study statistician. If an infant does not consume at least 60 mL/kg/day of breastmilk by day 10 of chronological age, the mother-infant dyad will be administratively withdrawn from the study.
DELIVERY OF INTERVENTION Mothers of infants randomized to the intervention arm will express their breast milk into a standardized measurement cup (or PDHM can be used). Clinical research staff will mix human milk fortifier (HMF) in human milk (either MOM or PDHM, if available) per manufacturer specifications per feed for a minimum of 21 days.
Dyads in both arms will continue to receive the guideline-driven standard of care, access to breast pumps, and follow the volume target and trajectory protocol until they meet stopping criteria. Data will be collected every 24 hours, including a log at every feed, regardless of study arm assignment.
If an infant in either arm does not meet protocolized minimum volume targets or trajectories AND that infant meets weight-based safety net criteria, clinicians will intervene per judgment aligned with national and local protocols.
The intervention will not be continued once the infant meets stopping criteria with the goal of the infant having fully transitioned to exclusive breast milk feeding by then.
STOPPING CRITERIA After the minimum duration of 21 days post-randomization, hospitalized infants should continue to receive volume targeted feeding with or without HMF for as long as they receive expressed breast milk. Once infants transition to full, direct breastfeeding in preparation for discharge or are being discharged per clinician discretion, they will stop adhering to the volume targets and infants in the intervention group will stop receiving fortified human milk.
DISCHARGE FROM FACILITY TO HOME After stopping criteria are met, routine clinical care around infant feeding will be provided. Infants can be discharged home when deemed clinically appropriate per facility protocols and clinician judgment. The guideline-driven standard of care will encourage all mothers to exclusively breastfeed their infants prior to discharge and to continue doing so after discharge.
POST-DISCHARGE FACILITY VISITS All dyads will be followed up at 2 weeks of age, 4 weeks of age, and 3 months of chronological age.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Routine fortification of human milk with human milk fortifier using a standardized clinical protocol
Enrolled participants in the intervention arm will be exposed to:
* Provision of guideline-driven standard of care specifically for VPT/ VLBW babies
* Encouragement to express breast milk with breast pumps
* Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT/ VLBW babies based on birthweight
* Fortification of human milk with HMF
* Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline AND stopping routine fortification of human milk)
Human Milk Fortifier
Human milk fortifier added to expressed human milk (mother's own milk or pasteurized donor human milk) per feed per manufacturer's instructions for a minimum of 21 days (in-facility provision only)
* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding
* Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
Volume targets
* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding
* Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
No routine fortification of human milk using a standardized clinical protocol
Participants in the control group will have the same exposures as the participants in the intervention group EXCEPT for the human milk consumed will not be fortified with HMF.
* Provision of guideline-driven standard of care specifically for VPT/ VLBW babies
* Encouragement to express with breast pumps
* Adherence to a clinical guideline including targets for initiation and advancement of breast milk feeding for VPT/ VLBW babies based on birthweight
* Adherence to standardized stopping criteria (i.e., stopping adherence to clinical feeding guideline)
Volume targets
* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding
* Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
Interventions
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Human Milk Fortifier
Human milk fortifier added to expressed human milk (mother's own milk or pasteurized donor human milk) per feed per manufacturer's instructions for a minimum of 21 days (in-facility provision only)
* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding
* Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
Volume targets
* Clinical feeding guideline including targets for initiation and advancement of breast milk feeding
* Provision of guideline-driven standard of care \[facility-based lactation support/feeding counseling + KMC + WASH package (referred to as facility-based FSP+) and breast pumps\]
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mother and infant alive during screening
* Mother age 18+ years
* Lives within catchment areas of the facility
* Mother intends to stay in catchment area of the study facility for at least 3 months
* At randomization: Infant receiving at least 60 mL/kg/day of human milk\*\*\*
Exclusion Criteria
* Congenital abnormalities or acquired conditions that interfere with feeding or placement of nasogastric/orogastric tube \[cleft lip/palate, toxoplasmosis, other agents, rubella, cytomegalovirus, and herpes (TORCH), Trisomy 21, congenital cardiac defect, neural tube defect, gastrointestinal tract anomalies, hydrocephalus, NEC\]
* Severe birth asphyxia
* Critically ill (i.e. not on enteral feeds)
* Unknown date of birth and unknown gestational age
48 Hours
ALL
Yes
Sponsors
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Boston Children's Hospital
OTHER
Brigham and Women's Hospital
OTHER
Emory University
OTHER
Muhimbili University of Health and Allied Sciences
OTHER
Jawaharlal Nehru Medical College
OTHER
PATH
OTHER
University of North Carolina
OTHER
Harvard School of Public Health (HSPH)
OTHER
Responsible Party
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Katherine Semrau
Deputy Director, Ariadne Labs & Director, BetterBirth Program; Associate Professor, HSPH
Principal Investigators
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Katherine Semrau, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Ariadne Labs | Harvard TH Chan School of Public Health and Brigham and Womens Hospital
Locations
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Ballari Medical College and Research Centre
Ballary, Karnataka, India
KLES Dr Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka, India
JJM Medical College
Davangere, Karnataka, India
Niloufer Hospital
Hyderabad, Telangana, India
Countries
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Central Contacts
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Facility Contacts
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Durgappa, MD
Role: primary
Roopa Bellad, MD
Role: primary
Gowdar Guruprasad, MD, DCH, DNB, DM
Role: primary
Other Identifiers
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IRB23-0304
Identifier Type: -
Identifier Source: org_study_id
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