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OpenTrials
Completed

NCT Number: NCT04639518

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

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).

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Key information

Conditions

Pre-term Infant

Age range

Up to 10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Nuernberg, Nuremberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Growth

    Time frame: 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

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

Secondary outcomes

  1. Weight at other time points

    Time frame: 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

    Changes in weight gain (g/day and g/kg/day)

  2. Other growth parameter (length)

    Time frame: 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

    Change in length (cm/week)

  3. Other growth parameter (head circumference)

    Time frame: 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

    Change in head circumference (cm/week)

  4. Anthropometric z-scores for weight, length and head circumference

    Time frame: 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

    Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed

  5. Feeding intake at neonatal unit

    Time frame: 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)

    Neonatal unit feeding questionnaire capturing timing, type, rate and amount of feeding (parenteral & enteral), gastric residual volumes, number of missed feedings

  6. Stool frequency at neonatal unit

    Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)

    Stool frequency (range from 0-20 times a day) collected via neonatal unit questionnaire

  7. Stool consistency at neonatal unit

    Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)

    Stool consistency (watery, mushy soft, runny, formed, hard) collected via neonatal unit questionnaire

  8. Bloody stools at neonatal unit

    Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)

    Bloody stools (yes or no) collected via neonatal unit questionnaire

  9. GI symptoms at neonatal unit

    Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)

    GI symptoms (incidence of abdominal distention, regurgitation, spitting and vomiting) collected via neonatal unit questionnaire

  10. Feeding intake after discharge

    Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits

    Parent-reported 3-Day Intake Diary capturing the total number of bottles of formula and approximate volumes consumed per day

  11. Stool frequency after discharge

    Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits

    Stool frequency captured via parent-reported 3-Day Intake Diary

  12. Stool consistency after discharge

    Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits

    Stool frequency captured via parent-reported 3-Day Intake Diary

  13. GI symptoms after discharge

    Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits

    GI symptoms (such as presence of stomach ballooning, bloody stools, regurgitation, spitting-up and vomiting) captured via parent-reported 3-Day Intake Diary

  14. GI-related behaviors after discharge

    Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits

    GI-related behaviors (such as crying and sleep quality) captured via parent-reported 3-Day Intake Diary

  15. Serum biomarkers for protein status

    Time frame: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD

    Serum albumin and blood urea nitrogen (BUN)

  16. Serum biomarkers for bone health

    Time frame: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD

    Serum P, alkaline phosphatase, calcium and creatinine

  17. Urine biomarkers for bone health

    Time frame: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD

    Urinary Ca, P and creatinine

  18. Vitamin D

    Time frame: FEF Day 1, Neonatal Unit Discharge and at 60 days PD

    Vitamin D

  19. Fecal microbiota

    Time frame: Baseline, FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, at 30 day-PD and 60 days PD

    Fecal microbiota composition, diversity and metabolism markers (SCFAs)

  20. Fecal markers for gut health / maturation and immune status

    Time frame: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD

    Fecal levels of calprotectin, alpha 1 antitrypsin, pancreatic elastase (i.e. chymotrypsin-like elastase family, member 3B (CELA3B)), Human beta-defensin 2 (HBD2) and secretory IgA

  21. Urine markers for gut health / maturation and immune status

    Time frame: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD

    Urinary level (spot urine sample) of intestinal fatty acid binding protein (iFABP)

  22. AE reporting

    Time frame: From the time the mother has consented to the infant's participation in the study until the 60 days PD visit

    Number of AEs through investigator-confirmed AE reporting

  23. Bayley-III scores

    Time frame: At 12, 18, and 24 months

    Bayley scales of Infants and Toddler development - 3rd edition

  24. Developmental Milestone scores

    Time frame: At 12, 18, and 24 months

    Parent-reported achievements of specific-age appropriate milestones (yes/no reponses to child performing specific milestones or not)

  25. Child temperament scores

    Time frame: At 12, 18, and 24 months

    Parent-reported child temperament questionnaire

  26. Number of healthcare usage

    Time frame: At 12, 18, and 24 months

    Retrospective paret-reported recall of the number of healthcare usage and hospitalizations

  27. Feeding patterns

    Time frame: At 12, 18, and 24 months

    Feeding practice outcomes collected retrospectively at each visit via a parent-reported questionnaire related to breastfeeding duration, prevalence of formula feeding, and age at initiation of complementary feeding

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Nov 20, 2020
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.