Actively Recruiting
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-08
188
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of a liquid supplement containing two specific human milk oligosaccharides (2'-fucosyllactose and lacto-N-neotetraose) on feeding tolerance, growth, and certain adverse events in preterm infants. This post-market study compares infants receiving the supplement with historical data from infants who followed the same nutrition protocols but did not receive the supplement. The aim is to understand how this supplement affects time to reach full enteral feeding, growth, and safety in a real-world setting. The study involves giving the HMO liquid supplement to preterm infants 3 to 4 times daily, separately from feedings. This supplement is designed to be administered without mixing into other feedings. The study compares these infants to a historical group from each site who were not exposed to the supplement but followed the same local feeding protocols. There are no placebo or masking procedures. Participants will be monitored from birth until they reach full enteral feeding, typically 1 to 3 weeks, with further assessments up to 13 weeks until discharge from the neonatal intensive care unit (NICU). Researchers will evaluate feeding tolerance, gastrointestinal tolerance, weight gain, length growth, head circumference growth, as well as record any adverse or serious adverse events during this period. The study tracks growth and safety outcomes to better understand the supplement's impact on preterm infant health.
CONDITIONS
Brief 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 obtained from a parent or legally acceptable representative
- Parent or representative is of legal age, understands study documents, and can follow study requirements
- 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 not reached full enteral feeding
You will not qualify if you...
- Infant is clinically unstable, including signs of sepsis, low blood pressure, or receiving vasopressor drugs
- 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 (e.g., heart disease, skeletal dysplasia, trisomy 21, Turner syndrome)
- Other medical conditions making participation inappropriate
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From birth until achievement of full enteral feeding (1 to 3 weeks)
Participants receive a liquid supplement containing two specific human milk oligosaccharides (HMOs) given 3-4 times a day, not mixed with any feeding, while feeding tolerance and growth are monitored.
Multiple visits up to NICU discharge (up to 13 weeks)
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
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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