Clinical trial NCT04639518: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pre-term Infant
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2020-11-20
Enrollment: 70
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Two sequential sub-studies
Primary purpose: OTHER

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Growth
timeFrame: 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:
measure: Weight at other time points
timeFrame: 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
measure: Other growth parameter (length)
timeFrame: 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
measure: Other growth parameter (head circumference)
timeFrame: 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
measure: Anthropometric z-scores for weight, length and head circumference
timeFrame: 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
measure: Feeding intake at neonatal unit
timeFrame: 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)
measure: Stool frequency at neonatal unit
timeFrame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
measure: Stool consistency at neonatal unit
timeFrame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
measure: Bloody stools at neonatal unit
timeFrame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
measure: GI symptoms at neonatal unit
timeFrame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
measure: Feeding intake after discharge
timeFrame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
measure: Stool frequency after discharge
timeFrame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
measure: Stool consistency after discharge
timeFrame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
measure: GI symptoms after discharge
timeFrame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
measure: GI-related behaviors after discharge
timeFrame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
measure: Serum biomarkers for protein status
timeFrame: 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
measure: Serum biomarkers for bone health
timeFrame: 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
measure: Urine biomarkers for bone health
timeFrame: 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
measure: Vitamin D
timeFrame: FEF Day 1, Neonatal Unit Discharge and at 60 days PD
measure: Fecal microbiota
timeFrame: Baseline, FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, at 30 day-PD and 60 days PD
measure: Fecal markers for gut health / maturation and immune status
timeFrame: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD
measure: Urine markers for gut health / maturation and immune status
timeFrame: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD
measure: AE reporting
timeFrame: From the time the mother has consented to the infant's participation in the study until the 60 days PD visit
measure: Bayley-III scores
timeFrame: At 12, 18, and 24 months
measure: Developmental Milestone scores
timeFrame: At 12, 18, and 24 months
measure: Child temperament scores
timeFrame: At 12, 18, and 24 months
measure: Number of healthcare usage
timeFrame: At 12, 18, and 24 months
measure: Feeding patterns
timeFrame: At 12, 18, and 24 months
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg
city: Bydgoszcz
country: Poland
facility: Klinika Neonatologii, Szpital Uniwersyteck
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nove Zamky
country: Slovakia
facility: Fakultna nemocnica s poliklinikou Nove Zamky
Study officials:
References: