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

NCT04639518 | Completed

• 1 other identifier: 18.09.INF
• Study Type: interventional
• Target: 28
• Locations: 3 countries
• Sites: 4

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).

Conditions

Pre-term Infant

Outcome Measures

Primary Outcomes (1)

• Growth

  Weight-adjusted weight gain (g/kg/day)

  From FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier

Secondary Outcomes (27)

• Weight at other time points

  From Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months

• Other growth parameter (length)

  From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months

• Other growth parameter (head circumference)

  From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months

• Anthropometric z-scores for weight, length and head circumference

  From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months

• Feeding intake at neonatal unit

  Baseline + weekly over 3 consecutive days starting on pre-FEF Day1 + weekly over 3 consecutive days starting on FEF Day1 until Neonatal Unit Discharge (on average 7 weeks after birth)

Study Arms (2)

Sub-study 1

EXPERIMENTAL

Pre-term formulas with HMO

Other: Preterm formulas with HMO

Sub-study 2

EXPERIMENTAL

Pre-term formulas without HMO

Other: Preterm formulas without HMO

Interventions

Preterm formulas with HMO 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 1

Preterm formulas without HMO 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

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
• Infants' birth weight ≤1500 g and AGA.
• Infant's gestational age \< 37 weeks.
• Infant is clinically stable and does not have deteriorating respiratory function after birth.
• Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.

You may not qualify if:

• Parent(s) not willing / not able to comply with the requirements of study protocol.
• Infant is experiencing early onset sepsis.
• Major congenital or chromosomal abnormality known to affect growth.
• Liver failure.
• Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).
• Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk.
• Infant's participation in another interventional clinical trial.
• Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (4)

Klinikum Nuernberg

Nuremberg, Germany

Location

Klinika Neonatologii, Szpital Uniwersyteck

Bydgoszcz, 85-067, Poland

Location

Univerzitna nemocnica Martin

Martin, 3659, Slovakia

Location

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, 940 34, Slovakia

Location

MeSH Terms

Interventions

Health Maintenance Organizations

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two sequential sub-studies

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 20, 2020
• Study Start: September 10, 2020
• Primary Completion: June 30, 2024
• Study Completion: April 28, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); DE (1); SL (2)