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

Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants: a Multi-centered, Open-label Clinical Trial

NCT04639518•Société des Produits Nestlé (SPN)

View on ClinicalTrials.gov

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).

Detailed 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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Written informed consent has been obtained from one or both parent(s) /legally acceptable 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 function after 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 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's milk.
•7. Infant's participation in another interventional clinical trial.
•8. Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).

Locations (4)

Klinikum Nuernberg

Nuremberg, Germany

Klinika Neonatologii, Szpital Uniwersyteck

Bydgoszcz, Poland

Univerzitna nemocnica Martin

Martin, Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, Slovakia

Key Dates

Start Date

September 10, 2020

Primary Completion Date

June 30, 2024

Completion Date

April 28, 2025

Last Updated

January 16, 2026

Enrollment

ACTUAL participants

Conditions

Pre-term Infant

Interventions

Preterm formulas with HMO

OTHER

Preterm formulas without HMO

OTHER