Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants

March 20, 2023 updated by: Société des Produits Nestlé (SPN)

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux - Hopital des Enfants
      • Grenoble, France, 38043
        • Hôpital Couple Enfant
      • Marseille, France, 13000
        • Hopital Nord
      • Nancy, France, 54035
        • Maternité Régionale Universitaire A. Pinard - CHRU Nancy
      • Nantes, France, 44093
        • Hôpital femme-maternité
      • Orléans, France, 45100
        • CHR Orléans - Hôpital de la Source
      • Pau, France, 64046
        • Centre Hospitalier de Pau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Written informed consent has been obtained from the parents/legally acceptable representative (LAR).

Exclusion Criteria:

  • 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.
  • Liver failure.
  • Severe intrauterine growth restriction (IUGR) as defined by having birth weight less than 2nd percentile on the Fenton growth chart.
  • Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) .
  • Infant in critical condition needing intubation or inotropic agents for treatment.
  • Infant requiring prolonged (more than 3 doses) of steroid treatment.
  • Infants' participation in another interventional clinical trial that would have significant impact on current study's results.
  • Infants who have already achieved Full Enteral Feeding (FEF) prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 mL/kg/day).

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Formula
The experimental group will receive a liquid supplement containing 2 specific HMOs
Dietary supplement: HMO supplement
HMO supplement will be given three times a day, not mixed with any feeding.
Placebo Comparator: Control Formula
The control group will receive a liquid placebo
Dietary supplement: Placebo comparator
Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feeding tolerance
Time Frame: Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment)
The primary objective is to demonstrate non-inferiority in feeding tolerance (defined as number of days to reach full enteral feeding) of preterm infants receiving a liquid supplement composed of 2 HMOs compared to those receiving the placebo.
Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length
Time Frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Through standardized measurement for neonates
Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Head circumference
Time Frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Through standardized measurement for neonates
Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Weight gain
Time Frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Through standardized measurement for neonates
Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Assessment of infant illnesses and infections
Time Frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Through Adverse Event reporting
Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Tolerance to feeding regimen
Time Frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Through neonatal unit records
Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Physical signs of gastrointestinal tolerance
Time Frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Through neonatal unit records
Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Breast milk composition such as energy, carbohydrate, proteins and fats using mid-infrared transmission methods
Time Frame: Change from enrolment (baseline) (if feasible) until FEF Day 21, average of 5 weeks
Macro and micro nutrients
Change from enrolment (baseline) (if feasible) until FEF Day 21, average of 5 weeks
Standard Adverse Event reporting for safety assessment
Time Frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Through investigator-confirmed Adverse Event reporting
Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Fecal microbiota composition and diversity
Time Frame: Change from enrolment (baseline) through two-months corrected age visit
Fecal microbiota composition and diversity will be assessed using next generation shotgun metagenomics sequencing to provide taxonomic composition and diversity metrics. Quantifiable changes from baseline and between feeding groups in absolute concentrations of bifidobacteria will be assessed using quantifiable polymerase chain reaction
Change from enrolment (baseline) through two-months corrected age visit
Fecal metabolic profile
Time Frame: Change from enrolment (baseline) through two-months corrected age visit
Measures of fecal metabolism will include fecal power of hydrogen (pH) and fecal organic acids (including lactate, propionate, butyrate, acetate, isobutyrate, isovalerate, valerate, formic acid, hexanoic acid, caprylic acid, capric acid, pelargonic acid, undecanoic acid, dodecanoic acid and total fecal organic acids).
Change from enrolment (baseline) through two-months corrected age visit
Markers for gut health, gut maturation and immune status
Time Frame: Change from enrolment (baseline) (if feasible) until FEF Day 21

Markers for gut health, gut maturation and immune status will be assessed through measures of:

Fecal level of calprotectin, alpha 1 antitrypsin, pancreatic elastase, human beta-defensin 2 , secretory immunoglobulin A, Plasma level of citrulline and twenty four additional Amino Acids Urinary levels of intestinal fatty acid binding protein
Change from enrolment (baseline) (if feasible) until FEF Day 21
Early life development outcomes
Time Frame: At 12 Months Corrected age Visit, 18 Months Corrected age Visit, and 24 Months Corrected age Visit

Aligned with standard routine care, post-discharge clinical assessments of preterm infants include clinically relevant events since last visit, feeding practice (complementary feeding, adequate food intake), Gastrointestinal-related symptoms (sleep, crying), somatic examination (physical examination of skin, digestion, abdomen, hip), Neurosensory Examination (hearing / visual function, gross motor), Relationship and Communication Development (normal or abnormal communication, neurological or psychomotor examination, relationship

/ behavior disorders). All clinical assessments will be standardized across sites. Ages and Stages Questionnaire-3 will be administered to parents to assess their report of child's developmental progress based on Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social domains.
At 12 Months Corrected age Visit, 18 Months Corrected age Visit, and 24 Months Corrected age Visit
Cognitive development outcomes
Time Frame: 24 Months Corrected age Visit
Will be assessed through the composite scores or scale scores of the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III)
24 Months Corrected age Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Société des Produits Nestlé (SPN)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jean-Michel Hascoët, Prof, Chru Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17.02.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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