Completed

Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial

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What is being tested

HMO supplement

+ Placebo comparator

Dietary Supplement
Who is being recruted

Urogenital Diseases+3

+ Female Urogenital Diseases and Pregnancy Complications

+ Obstetric Labor Complications

+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: August 2018
See protocol details

Summary

Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 6, 2018

Actual date on which the first participant was enrolled.

This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content. This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age. The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.

Official TitleUse of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial
NCT03607942
Principal SponsorSociété des Produits Nestlé (SPN)
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

86 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsObstetric Labor ComplicationsObstetric Labor, PrematurePregnancy ComplicationsPremature Birth

Criteria

5 inclusion criteria required to participate
Infant's birth weight ≤1700 g.
Infant's gestational age ≥ 27 weeks + 0 days and ≤ 32 weeks + 6 days.
Infant is clinically stable
Infants are eligible to start HMOs / placebo as soon as possible after birth, but still within the first 7 days of life.
Show More Criteria
11 exclusion criteria prevent from participating
Parents not willing / not able to comply with the requirements of study protocol.
Infants receiving ongoing prophylactic antifungal therapies.
Infants experiencing early onset sepsis.
Major congenital or chromosomal abnormality known to affect growth.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
The experimental group will receive a liquid supplement containing 2 specific HMOs

Group II

Placebo
The control group will receive a liquid placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Suspended

CHU de Bordeaux - Hôpital des Enfants

Bordeaux, FranceOpen CHU de Bordeaux - Hôpital des Enfants in Google Maps
Suspended

Hôpital Couple Enfant

Grenoble, France
Suspended

Hôpital Nord

Marseille, France
Suspended

Maternité Régionale Universitaire A. Pinard - CHRU Nancy

Nancy, France
Completed7 Study Centers