MedTrace Logo

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

NCT04639518 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-01-16

No results posted yet for this 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).

Conditions

  • Pre-term Infant

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2024-06-30
Completion
2025-04-28

Countries

  • Germany
  • Poland
  • Slovakia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04639518 on ClinicalTrials.gov