Clinical trial NCT03607942: Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants
Official title: Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 86
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content.

This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age.

The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.


Eligibility criteria: Inclusion Criteria:

* Infant's birth weight ≤1700 g.
* Infant's gestational age ≥ 27 weeks + 0 days and ≤ 32 weeks + 6 days.
* Infant is clinically stable
* Infants are eligible to start HMOs / placebo as soon as possible after birth, but still within the first 7 days of life.
* Written informed consent has been obtained from the parents/legally acceptable representative (LAR).

Exclusion Criteria:

* Parents not willing / not able to comply with the requirements of study protocol.
* Infants receiving ongoing prophylactic antifungal therapies.
* Infants experiencing early onset sepsis.
* Major congenital or chromosomal abnormality known to affect growth.
* Liver failure.
* Severe intrauterine growth restriction (IUGR) as defined by having birth weight less than 2nd percentile on the Fenton growth chart.
* Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) .
* Infant in critical condition needing intubation or inotropic agents for treatment.
* Infant requiring prolonged (more than 3 doses) of steroid treatment.
* Infants' participation in another interventional clinical trial that would have significant impact on current study's results.
* Infants who have already achieved Full Enteral Feeding (FEF) prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 mL/kg/day).

Primary outcomes:
measure: Feeding tolerance
timeFrame: Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment)
Secondary outcomes:
measure: Length
timeFrame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
measure: Head circumference
timeFrame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
measure: Weight gain
timeFrame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
measure: Assessment of infant illnesses and infections
timeFrame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
measure: Tolerance to feeding regimen
timeFrame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
measure: Physical signs of gastrointestinal tolerance
timeFrame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
measure: Breast milk composition such as energy, carbohydrate, proteins and fats using mid-infrared transmission methods
timeFrame: Change from enrolment (baseline) (if feasible) until FEF Day 21, average of 5 weeks
measure: Standard Adverse Event reporting for safety assessment
timeFrame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
measure: Fecal microbiota composition and diversity
timeFrame: Change from enrolment (baseline) through two-months corrected age visit
measure: Fecal metabolic profile
timeFrame: Change from enrolment (baseline) through two-months corrected age visit
measure: Markers for gut health, gut maturation and immune status
timeFrame: Change from enrolment (baseline) (if feasible) until FEF Day 21
measure: Early life development outcomes
timeFrame: At 12 Months Corrected age Visit, 18 Months Corrected age Visit, and 24 Months Corrected age Visit
measure: Cognitive development outcomes
timeFrame: 24 Months Corrected age Visit
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital des Enfants
city: Grenoble
country: France
facility: Hôpital Couple Enfant
city: Marseille
country: France
facility: Hôpital Nord
city: Nancy
country: France
facility: Maternité Régionale Universitaire A. Pinard - CHRU Nancy
city: Nantes
country: France
facility: Hôpital femme-maternité
city: Orléans
country: France
facility: CHR Orléans - Hôpital de la Source
city: Pau
country: France
facility: Centre Hospitalier de Pau
Study officials:
affiliation: CHRU Nancy
name: Jean-Michel Hascoët, Prof
role: STUDY_DIRECTOR
References: