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Can a simple feeding protocol help the tiniest babies thrive?

NCT ID NCT06765863

Disease control Sponsor: Harvard School of Public Health (HSPH) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether feeding very low birthweight or very preterm infants a standardized fortified human milk protocol in the NICU leads to better growth, less illness, and lower death rates compared to usual care. About 776 infants in India will take part. The key approach is adding a human milk fortifier to breast milk according to a strict guideline for at least 21 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human milk fortifier (dietary supplement added to breast milk)
What this could lead to
If successful, this could establish a simple, scalable feeding protocol that helps fragile newborns grow better and face fewer complications in the NICU.
What could go wrong
This is a single-country trial with 776 infants, so results may not apply everywhere. The intervention is only given in the hospital, so benefits may not last after discharge.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 776 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 48 hours

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Very low birthweight Very preterm infant

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ballari Medical College and Research Centre

    RECRUITING

    Ballary, Karnataka, India

  • JJM Medical College

    RECRUITING

    Davangere, Karnataka, India

  • KLES Dr Prabhakar Kore Hospital & Medical Research Center

    NOT_YET_RECRUITING

    Belagavi, Karnataka, India

  • Niloufer Hospital

    RECRUITING

    Hyderabad, Telangana, India

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