Effects of a supplement with human milk oligosaccharides on feeding in preterm infants

Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study

This study tests if a special liquid supplement made from human milk can help preterm infants eat better and grow stronger.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 188 (estimated)
• Ages: 0 Days to 14 Days
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (Industry-sponsored)
• Locations: 6 sites (Linz and 5 other locations)
• Trial ID: NCT06212427 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of a liquid supplement containing two specific human milk oligosaccharides, 2'-fucosyllactose and lacto-N-neotetraose, on feeding tolerance and growth in preterm infants. The research is conducted in a real-world setting, focusing on infants born at or below 34 weeks gestational age and weighing less than 2500 grams. The study aims to assess how well these infants tolerate feeding and monitor any adverse events associated with the supplement.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at or below 34 weeks gestational age and weighing less than 2500 grams.

Not a fit: Patients who are clinically unstable or have significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve feeding tolerance and growth outcomes for preterm infants.

How similar studies have performed: Other studies have shown promising results with similar approaches using human milk oligosaccharides in preterm infants.

Eligibility criteria

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

Where this trial is running

Linz and 5 other locations

• 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)

Study contacts

• Study coordinator: Inez Sroda

Conditions Premature Infant; Low Birthweight Infant; Human Milk Oligosaccharides; Feeding tolerance; Growth