Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants

Last updated: February 6, 2025
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Preterm formulas with HMO

Preterm formulas without HMO

Clinical Study ID

NCT04639518
18.09.INF
  • Ages < 10
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent has been obtained from one or both parent(s) /legallyacceptable representative (LAR) in accordance with local regulation.

  2. Infants' birth weight ≤1500 g and AGA.

  3. Infant's gestational age < 37 weeks.

  4. Infant is clinically stable and does not have deteriorating respiratory functionafter birth.

  5. Infant is eligible to start experimental formula after 24 hours of trophic feeding,but still within the first 10 days (≤240 hours) of life.

Exclusion

Exclusion Criteria:

  1. Parent(s) not willing / not able to comply with the requirements of study protocol.

  2. Infant is experiencing early onset sepsis.

  3. Major congenital or chromosomal abnormality known to affect growth.

  4. Liver failure.

  5. Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).

  6. Infant who has siblings with diagnosed allergies or intolerances to lactose or cow'smilk.

  7. Infant's participation in another interventional clinical trial.

  8. Infant has already achieved FEF prior to enrolment, using the definition accepted byNeonatal Unit as per standard practice (150 mL/kg/day).

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Preterm formulas with HMO
Phase:
Study Start date:
September 10, 2020
Estimated Completion Date:
December 31, 2026

Study Description

This is a multi-center, open-label trial to be conducted in up to 70 pre-term infants in order to evaluate the safety and suitability of two feeding systems as they would typically be used in the neonatal care unit. Growth (in comparison to recommended growth goals), feeding tolerance, biochemical parameters, and adverse event reporting will be evaluated.

The two feeding systems will be tested in two sub-studies to be conducted sequentially: sub-study 1 will evaluate a two-staged feeding system with HMOs in up to 35 pre-term infants; sub-study 2 will evaluate a two-staged feeding system without HMOs in up to 35 pre-term infants.

A follow up period from 12 to 24 months have been added to the study protocol, to assess the neurocognitive development of the subjects during this period.

Connect with a study center

  • Klinikum Nuernberg

    Nuernberg,
    Germany

    Site Not Available

  • Klinika Neonatologii, Szpital Uniwersyteck

    Bydgoszcz, 85-067
    Poland

    Site Not Available

  • Klinika Chorob Dzieci, Uniwersytecki Szpital Dzieciecy

    Kraków, 30-663
    Poland

    Site Not Available

  • Clinical Center of Serbia

    Belgrad, 11000
    Serbia

    Site Not Available

  • Univerzitna nemocnica Martin

    Martin, 3659
    Slovakia

    Site Not Available

  • Fakultna nemocnica s poliklinikou Nove Zamky

    Nove Zamky, 940 34
    Slovakia

    Site Not Available

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