Fortifying human milk for very preterm and low birthweight infants

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 776 (estimated)
• Ages: N/A to 48 Hours
• Sex: All
• Sponsor: Harvard School of Public Health (HSPH) (other)
• Locations: 4 sites (Ballary, Karnataka and 3 other locations)
• Trial ID: NCT06765863 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Other studies have shown promising results with similar approaches to human milk fortification, indicating potential for success in this trial.

Eligibility 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 this trial is running

Ballary, Karnataka and 3 other locations

• Ballari Medical College and Research Centre — Ballary, Karnataka, India (RECRUITING)
• KLES Dr Prabhakar Kore Hospital & Medical Research Center — Belagavi, Karnataka, India (NOT_YET_RECRUITING)
• JJM Medical College — Davangere, Karnataka, India (RECRUITING)
• Niloufer Hospital — Hyderabad, Telangana, India (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

Conditions: Very Preterm Infant, Very Low Birthweight, very preterm, very low birthweight, fortification, human milk