Can a simple feeding protocol help the tiniest babies thrive?

NCT ID NCT06765863

First seen Jun 27, 2026 ยท 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 โ€” 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.

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As listed by the trial registrant

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

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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