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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kepler Universitätsklinikum Linz
  Linz, Austria Recruiting
• Evangelisches Waldkrankenhaus Spandau
  Berlin-Spandau, Germany Recruiting
• Kinderklinik Darmstadt
  Darmstadt, Germany Recruiting
• Uniklinik Heidelberg
  Heidelberg, Germany Recruiting
• Klinikum Nürnberg
  Nuremberg, Germany Recruiting
• Wilhelmstift Hamburg
  Hamburg, Germany Withdrawn

Study contacts

• Study coordinator: Inez Sroda
• Email: Inez.Sroda@rd.nestle.com
• Phone: +41217858259

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.