Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)

Last updated: June 12, 2024
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

HMO supplement

Clinical Study ID

NCT06212427
2211INF
  • Ages < 14
  • All Genders

Study 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], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent has been obtained from at least one parent (or otherlegally acceptable representative [LAR], if applicable)

  2. Infant's parent(s)/LAR is of legal age of majority, has parental authority, mustunderstand the consent form and other relevant study documents, and is willing andable to fulfil the requirements of the study protocol

  3. Infant gestational age is ≤ 34 weeks as determined by the first day of the mother'slast 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 buthas not yet reached full enteral feeding

Exclusion

Exclusion Criteria:

  1. Infant is clinically unstable, for example:

  2. Infant has hemodynamic instability as evidenced by clinical signs of sepsis,hypotension (MAP < 5th percentile for age for at least three hours), or isreceiving vasopressor drugs

  3. Infant has received an exchange transfusion within the past 48 hours

  4. Infant has had an episode of severe asphyxia at birth (PH less than 7.0)

  5. Infant has signs of necrotizing enterocolitis according to modified Bellstaging criteria (stage IIA or higher)

  6. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy,gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)

  7. Infant has other medical condition that, in the judgement of the investigator, wouldmake the child inappropriate for entry into the study

  8. Participation in another interventional clinical study that may interfere with theresults of this study

Study Design

Total Participants: 188
Treatment Group(s): 1
Primary Treatment: HMO supplement
Phase:
Study Start date:
November 20, 2023
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Kepler Universitätsklinikum Linz

    Linz, 4020
    Austria

    Active - Recruiting

  • Evangelisches Waldkrankenhaus Spandau

    Berlin-Spandau,
    Germany

    Active - Recruiting

  • Kinderklinik Darmstadt

    Darmstadt,
    Germany

    Active - Recruiting

  • Wilhelmstift Hamburg

    Hamburg,
    Germany

    Site Not Available

  • Uniklinik Heidelberg

    Heidelberg,
    Germany

    Active - Recruiting

  • Klinikum Nürnberg

    Nürnberg, 90419
    Germany

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.