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

Recruiting now · Not applicable

Conditions studied: Premature Infant, Low Birthweight Infant

In brief

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.

Key facts

Study ID: NCT06212427
Run by: Société des Produits Nestlé (SPN)
People needed: 188
Starts: 2023-11-20
Expected to finish: 2026-02-28
Last updated by the study team: 2025-12-08

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Kepler Universitätsklinikum Linz — Linz, Austria (enrolling)
Evangelisches Waldkrankenhaus Spandau — Berlin-Spandau, Germany (enrolling)
Kinderklinik Darmstadt — Darmstadt, Germany (enrolling)
Uniklinik Heidelberg — Heidelberg, Germany (enrolling)
Klinikum Nürnberg — Nuremberg, Germany (enrolling)
Wilhelmstift Hamburg — Hamburg, Germany

Full record on ClinicalTrials.gov

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