CompletedNot Applicable

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

India, Malawi, Tanzania632 participantsStarted 2024-05-08

Plain-language 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.

Who can participate

Age range

1 Minute

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

Community provider who was not trained to deliver the transition-to-home FSP+.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 hour after birth

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

Timeframe: 1 hour after birth

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

Timeframe: 24 hours

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

Timeframe: 24 hours

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

Timeframe: 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)

Timeframe: 6 weeks after initial facility discharge

Trial details

NCT IDNCT06390943

SponsorHarvard School of Public Health (HSPH)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-13

View on ClinicalTrials.gov More Low Birthweight trials

Plain-language summary

What they're measuring

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

Timeframe: 1 hour after birth

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

Timeframe: 1 hour after birth

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

Timeframe: 24 hours

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

Timeframe: 24 hours

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

Obj 2: Growth velocity (g/kg/d)

Timeframe: 6 weeks after initial facility discharge