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

Primary Purpose

Pre-term Infant

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Preterm formulas with HMO

Preterm formulas without HMO

About this trial

This is an interventional other trial for Pre-term Infant

Eligibility Criteria

undefined - 10 Days (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

Klinika Neonatologii, Szpital Uniwersyteck
Klinika Chorob Dzieci, Uniwersytecki Szpital DzieciecyRecruiting
Clinical Center of Serbia
Univerzitna nemocnica MartinRecruiting
Fakultna nemocnica s poliklinikou Nove ZamkyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sub-study 1

Sub-study 2

Arm Description

Pre-term formulas with HMO

Pre-term formulas without HMO

Outcomes

Primary Outcome Measures

Growth

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

Secondary Outcome Measures

Weight at other time points

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

Other growth parameter (length)

Change in length (cm/week)

Other growth parameter (head circumference)

Change in head circumference (cm/week)

Anthropometric z-scores for weight, length and head circumference

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

Feeding intake at neonatal unit

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

Stool frequency at neonatal unit

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

Stool consistency at neonatal unit

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

Bloody stools at neonatal unit

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

GI symptoms at neonatal unit

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

Feeding intake after discharge

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

Stool frequency after discharge

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

Stool consistency after discharge

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

GI symptoms after discharge

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

GI-related behaviors after discharge

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

Serum biomarkers for protein status

Serum albumin and blood urea nitrogen (BUN)

Serum biomarkers for bone health

Serum P, alkaline phosphatase, calcium and creatinine

Urine biomarkers for bone health

Urinary Ca, P and creatinine

Vitamin D

Fecal microbiota

Fecal microbiota composition, diversity and metabolism markers (SCFAs)

Fecal markers for gut health / maturation and immune status

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

Urine markers for gut health / maturation and immune status

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

AE reporting

Number of AEs through investigator-confirmed AE reporting

Bayley-III scores

Bayley scales of Infants and Toddler development - 3rd edition

Developmental Milestone scores

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

Child temperament scores

Parent-reported child temperament questionnaire

Number of healthcare usage

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

Feeding patterns

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

Full Information

NCT ID

NCT04639518

First Posted

October 22, 2020

Last Updated

March 22, 2023

Sponsor

Société des Produits Nestlé (SPN)

1. Study Identification

Unique Protocol Identification Number

NCT04639518

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 10, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-term Infant

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

Two sequential sub-studies

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sub-study 1

Arm Type

Experimental

Arm Description

Pre-term formulas with HMO

Arm Title

Sub-study 2

Arm Type

Experimental

Arm Description

Pre-term formulas without HMO

Intervention Type

Other

Intervention Name(s)

Preterm formulas with HMO

Intervention Description

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

Intervention Name(s)

Preterm formulas without HMO

Intervention Description

Primary Outcome Measure Information:

Title

Growth

Description

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

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

Secondary Outcome Measure Information:

Title

Weight at other time points

Description

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

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

Title

Other growth parameter (length)

Description

Change in length (cm/week)

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

Title

Other growth parameter (head circumference)

Description

Change in head circumference (cm/week)

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

Title

Anthropometric z-scores for weight, length and head circumference

Description

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

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

Title

Feeding intake at neonatal unit

Description

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

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)

Title

Stool frequency at neonatal unit

Description

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

Time Frame

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

Title

Stool consistency at neonatal unit

Description

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

Time Frame

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

Title

Bloody stools at neonatal unit

Description

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

Time Frame

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

Title

GI symptoms at neonatal unit

Description

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

Time Frame

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

Title

Feeding intake after discharge

Description

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

Time Frame