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

Société des Produits Nestlé (SPN)28 enrolled

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pre-term Infant

Interventions

Preterm formulas with HMOOTHER

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 HMOOTHER

Eligibility

Sex: ALLMax age: 10 DaysHealthy volunteers:

Medical Language ↔ Plain English

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 \< 37 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).

Locations (4)

Klinikum Nuernberg

Nuremberg, Germany

Klinika Neonatologii, Szpital Uniwersyteck

Bydgoszcz, Poland

Univerzitna nemocnica Martin

Martin, Slovakia

Fakultna nemocnica s poliklinikou Nove Zamky

Nové Zámky, Slovakia

Outcomes

Primary Outcomes

Growth

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 Outcomes

Weight at other time points

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

Other growth parameter (length)

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

Other growth parameter (head circumference)

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

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

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

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

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)

Data from ClinicalTrials.gov

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Stool frequency at neonatal unit

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)

Stool consistency at neonatal unit

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)

Bloody stools at neonatal unit

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)

GI symptoms at neonatal unit

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)

Feeding intake after discharge

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