Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study

The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.

A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.

Study Overview

• Status: Recruiting
• Conditions: Premature Infant; Low Birthweight Infant
• Intervention / Treatment: Dietary supplement: HMO supplement

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inez Sroda; Phone Number: +41217858259; Email: Inez.Sroda@rd.nestle.com

Study Locations

• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Kepler Universitätsklinikum Linz
    • Contact: Melanie Gsollpointner
    • Principal Investigator: Judith Rittenschober-Boehm, Prof.
• Germany
  • Berlin-Spandau, Germany
    • Recruiting
    • Evangelisches Waldkrankenhaus Spandau
    • Contact: Lindsey Otten, Dr.; Email: lindsey.otten@jsd.de
    • Principal Investigator: Frank Jochum, Dr.
  • Darmstadt, Germany
    • Recruiting
    • Kinderklinik Darmstadt
    • Principal Investigator: Thomas Weiss, Dr.
    • Contact: Andrea Reichl; Email: Andrea.Reichl@kinderkliniken.de
  • Hamburg, Germany
    • Withdrawn
    • Wilhelmstift Hamburg
  • Heidelberg, Germany
    • Recruiting
    • Uniklinik Heidelberg
    • Principal Investigator: Christian Gille, Prof.
    • Contact: Suzanne Klein; Email: Susanne.Klein@med.uni-heidelberg.de
  • Nuremberg, Germany, 90419
    • Recruiting
    • Klinikum Nürnberg
    • Principal Investigator: Christian Fusch, Prof.
    • Contact: Mara Cabrera-Diaz; Email: Mara.CabreraDiaz@klinikum-nuernberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HMO supplement	Dietary supplement: HMO supplement; Liquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feeding tolerance	Time to reach full enteral feeding rate of 150 mL/kg/day	From birth until achievement of full enteral feeding (1 to 3 weeks)
Feeding tolerance	Time to reach cessation of parenteral feeding	From birth until achievement of full enteral feeding (1 to 3 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal tolerance	Through data collected from neonatal unit records	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)	Type, incidence, severity, seriousness, and relation to HMO supplement consumption as well as concomitant medications and non-pharmacological treatments. The incidence of specific illnesses of interest a. Necrotizing enterocolitis b Confirmed or suspected late-onset sepsis c. Bronchopulmonary dysplasia d. Retinopathy of prematurity	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Weight gain	Measured in kilograms per day	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Length gain	Measured in centimeters per week	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Head circumference gain	Measured in centimeters per week	From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Growth; Feeding tolerance; Human Milk Oligosaccharides
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 2211INF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No