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

NCT06212427 | Recruiting

• 1 other identifier: 2211INF
• Study Type: interventional
• Target: 188
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Premature Infant; Low Birthweight Infant

Keywords

Human Milk Oligosaccharides; Feeding tolerance; Growth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Gastrointestinal tolerance

  From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks

• Weight gain

  From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks

• Length gain

  From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks

• Head circumference gain

  From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks

• Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)

  From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks

Study Arms (1)

HMO supplement

OTHER

Dietary Supplement: HMO supplement

Interventions

HMO supplement DIETARY_SUPPLEMENT

Liquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding.

HMO supplement

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\], if applicable)
• 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
• Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
• Infant birth weight ≤ 2500g
• Infant postnatal age ≤ 14 days
• 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

You may not qualify if:

• Infant is clinically unstable, for example:
• 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
• Infant has received an exchange transfusion within the past 48 hours
• Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
• Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)
• Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
• Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
• Participation in another interventional clinical study that may interfere with the results of this study

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (6)

Kepler Universitätsklinikum Linz

Linz, 4020, Austria

RECRUITING

Evangelisches Waldkrankenhaus Spandau

Berlin-Spandau, Germany

RECRUITING

Kinderklinik Darmstadt

Darmstadt, Germany

RECRUITING

Wilhelmstift Hamburg

Hamburg, Germany

WITHDRAWN

Uniklinik Heidelberg

Heidelberg, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, 90419, Germany

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Inez Sroda

CONTACT

+41217858259; Inez.Sroda@rd.nestle.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 18, 2024
• Study Start: November 20, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

DE (5); AU (1)