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New supplement aims to help tiny preemies tolerate feeds and grow

NCT ID NCT06212427

Disease control Sponsor: Société des Produits Nestlé (SPN) 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether a liquid supplement containing two specific HMOs (2'-FL and LNnT) helps preterm infants (born at 34 weeks or earlier) tolerate feedings and grow better. About 188 infants will receive the supplement, and their progress will be compared to a historical group that did not get HMOs. The goal is to see if the supplement helps them reach full feeding faster and gain weight, length, and head size more steadily.

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 188 people

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

Started

Nov 2023

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

0 to 14 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\], if applicable) 2. Infant's parent(s)/LAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol 3. Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound 4. Infant birth weight ≤ 2500g 5. Infant postnatal age ≤ 14 days 6. Infant has tolerated trophic feeds (e.g., 10-15 mL/kg/day) for at least 24 hours but has not yet reached full enteral feeding Exclusion Criteria: 1. Infant is clinically unstable, for example: 1. Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP \< 5th percentile for age for at least three hours), or is receiving vasopressor drugs 2. Infant has received an exchange transfusion within the past 48 hours 3. Infant has had an episode of severe asphyxia at birth (PH less than 7.0) 4. Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher) 2. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome) 3. Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study 4. Participation in another interventional clinical study that may interfere with the results of this study

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Low birthweight infant Premature infant

How to take part

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

  1. The places running it

    5 sites in 2 countries. 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

  • Evangelisches Waldkrankenhaus Spandau

    RECRUITING

    Berlin-Spandau, Germany

  • Kepler Universitätsklinikum Linz

    RECRUITING

    Linz, 4020, Austria

  • Kinderklinik Darmstadt

    RECRUITING

    Darmstadt, Germany

  • Klinikum Nürnberg

    RECRUITING

    Nuremberg, 90419, Germany

  • Uniklinik Heidelberg

    RECRUITING

    Heidelberg, Germany

  • Wilhelmstift Hamburg

    WITHDRAWN

    Hamburg, Germany

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