Status:
RECRUITING
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
Lead Sponsor:
Société des Produits Nestlé (SPN)
Conditions:
Premature Infant
Low Birthweight Infant
Eligibility:
All Genders
Up to 14 years
Phase:
NA
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\...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT06212427
Start Date
November 20 2023
End Date
February 28 2026
Last Update
December 8 2025
Active Locations (6)
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1
Kepler Universitätsklinikum Linz
Linz, Austria, 4020
2
Evangelisches Waldkrankenhaus Spandau
Berlin-Spandau, Germany
3
Kinderklinik Darmstadt
Darmstadt, Germany
4
Wilhelmstift Hamburg
Hamburg, Germany