Actively Recruiting
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-08
188
Participants Needed
6
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent from at least one parent or legal representative
- Parent or legal representative is of legal age, understands study documents, and agrees to follow the study protocol
- Infant gestational age is 34 weeks or less
- Infant birth weight is 2500 grams or less
- Infant postnatal age is 14 days or less
- Infant has tolerated trophic feeds (10-15 mL/kg/day) for at least 24 hours but has not reached full enteral feeding
You will not qualify if you...
- Infant is clinically unstable, including signs of sepsis, low blood pressure, or use of vasopressors
- Infant received an exchange transfusion within the past 48 hours
- Infant had severe asphyxia at birth (pH less than 7.0)
- Infant shows signs of necrotizing enterocolitis (stage IIA or higher)
- Major congenital or chromosomal abnormalities such as heart disease, skeletal dysplasia, gastrointestinal obstruction, trisomy 21, or Turner syndrome
- Other medical conditions judged by the investigator to make the infant unsuitable for the study
- Participation in another interventional clinical study that could affect results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Kepler Universitätsklinikum Linz
Linz, Austria, 4020
Actively Recruiting
2
Evangelisches Waldkrankenhaus Spandau
Berlin-Spandau, Germany
Actively Recruiting
3
Kinderklinik Darmstadt
Darmstadt, Germany
Actively Recruiting
4
Wilhelmstift Hamburg
Hamburg, Germany
Withdrawn
5
Uniklinik Heidelberg
Heidelberg, Germany
Actively Recruiting
6
Klinikum Nürnberg
Nuremberg, Germany, 90419
Actively Recruiting
Research Team
I
Inez Sroda
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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