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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2022

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.

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.

Arms, Groups and Cohorts

  • Experimental: Sub-study 1
    • Pre-term formulas with HMO
  • Experimental: Sub-study 2
    • Pre-term formulas without HMO

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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) and at 30- and 60-days PD
    • Changes in weight gain (g/day and g/kg/day)
  • Other growth parameter (length)
    • Time Frame: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30- and 60-days PD
    • Change in length (cm/week)
  • Other growth parameter (head circumference)
    • Time Frame: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30- and 60-days PD
    • Change in head circumference (cm/week)
  • 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) and at 30- and 60-days PD
    • Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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
  • Vitamin D
    • Time Frame: FEF Day 1, Neonatal Unit Discharge and at 60 days PD
    • Vitamin D
  • 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)
  • 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
  • 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)
  • 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

Participating in This Clinical Trial

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 ≥ 27 weeks and ≤ 32 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).

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 10 Days

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nestlé
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Cecilia L Fumero, PhD, 0041 21 785 8328, cecilia.fumero@rdls.nestle.com

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