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

NCT ID: NCT04639518

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2025-04-28

Brief 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.

Conditions

Pre-term Infant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sub-study 1

Pre-term formulas with HMO

Group Type: EXPERIMENTAL

Preterm formulas with HMO

Intervention Type: OTHER

Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.

Sub-study 2

Pre-term formulas without HMO

Group Type: EXPERIMENTAL

Preterm formulas without HMO

Intervention Type: OTHER

Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.

Interventions

Preterm formulas with HMO

Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.

Intervention Type: OTHER

Preterm formulas without HMO

Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.

Intervention Type: OTHER

Eligibility Criteria

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).

• Maximum Eligible Age: 10 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinikum Nuernberg

Nuremberg, , Germany

Klinika Neonatologii, Szpital Uniwersyteck

Bydgoszcz, , Poland

Univerzitna nemocnica Martin

Martin, , Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, , Slovakia

Countries

Germany; Poland; Slovakia

Other Identifiers

18.09.INF

Identifier Type: -

Identifier Source: org_study_id