🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT06212427
Recruiting Not applicable

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

NCT06212427 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2023-11-20
Last updated
2025-12-08

Condition(s) studied

Premature InfantLow Birthweight Infant

Investigational drug(s) / intervention(s)

HMO supplement

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

Study 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.

Eligibility

Sex
ALL
Min age
0 Days
Max age
14 Days
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Kepler Universitätsklinikum Linz Linz 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 Germany Recruiting

More Société des Produits Nestlé (SPN) trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06212427 on ClinicalTrials.gov ↗ ← All trials in Germany