Fortifying human milk for very preterm and low birthweight infants
Official title: Low Birthweight and Preterm Infant Feeding Trial and Supportive Care Package (LIFT-UP): Randomized Controlled Trial of In-facility Fortification of Human Milk in India
Run by Harvard School of Public Health (HSPH) · NCT06765863 · Data updated 2026-11-12
This study is testing if feeding very preterm and low birthweight babies fortified human milk in NICUs can help them grow better, get less sick, and live longer compared to regular feeding methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 48 Hours |
| Sex | All |
| Enrollment | 776 (estimated) |
| Sponsor | Harvard School of Public Health (HSPH) Academic / other |
| Locations | 4 sites (Ballary, Karnataka and 3 other locations) |
| Status | Recruiting |
| Started | January 16, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT06765863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are very low birthweight infants (≤1.5kg) or very preterm infants (≤32 weeks gestational age) admitted to the NICU within specified timeframes.
✕Probably not a fit
Patients with congenital abnormalities or severe birth asphyxia, or those critically ill and not on enteral feeds, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The LIFT-UP trial evaluates the effectiveness of routinely feeding fortified human milk to very low birthweight (VLBW) and very preterm (VPT) infants in neonatal intensive care units (NICUs) across India, Malawi, and Tanzania. This multi-site, randomized controlled trial aims to determine if fortified human milk improves growth outcomes, reduces illness, and decreases mortality compared to standard feeding practices. Eligible infants and their mothers will be enrolled and monitored to assess the impact of the fortified feeding protocol on health outcomes. The study will provide insights into the benefits of human milk fortification in vulnerable infant populations.
Why it matters
Potential benefit: If successful, this approach could significantly improve growth and health outcomes for very preterm and low birthweight infants in NICUs.
How similar studies have gone: Other studies have shown promising results with similar approaches to human milk fortification, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Very LBW (≤1.5kg)\* or very preterm (≤32 weeks) infants admitted to NICU at study facility within 24 hours of birth for in-born infants and up to 48 hours for out-born\*\* * 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: * Lives outside the defined catchment area * 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
Where it's running
-
Ballari Medical College and Research Centre
Ballary, Karnataka, India Recruiting -
JJM Medical College
Davangere, Karnataka, India Recruiting -
Niloufer Hospital
Hyderabad, Telangana, India Recruiting -
KLES Dr Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka, India Not yet recruiting
Study contacts
- Principal investigator: Katherine Semrau, PhD, MPH — Ariadne Labs | Harvard TH Chan School of Public Health and Brigham and Womens Hospital
- Study coordinator: Ilana Dzuba, MHS
- Email: idzuba@ariadnelabs.org
- Phone: 617-384-6555
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effect of donor milk or formula and fortification strategies on outcomes in very preterm infants
In very preterm babies, the study tests whether supplementing the infant's mother's milk with pasteurized donor milk or preterm formula, and using routine versus selective fortification, can improve survival without NEC and support development.
-
Air conditioning and energy support for older adults in Boston
This project will test whether giving window air conditioners and a later electricity subsidy to older adults without home cooling improves heat-related health, comfort, and healthcare use.
-
Zinc supplementation for infants with severe infections in Tanzania
This study is testing if giving zinc to young infants in Tanzania who are hospitalized with serious infections can help them recover better and live longer.
-
Culturally tailored diet intervention for adults in Puerto Rico
This study is testing a special diet plan designed for adults in Puerto Rico to see if it can help reduce heart and diabetes risks over two years.
-
Understanding health trends in Puerto Rico
This study is trying to understand health trends in Puerto Rico by looking at diet, mental health, and heart health in adults aged 30-75 over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.