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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
86
HMO supplement will be given three times a day, not mixed with any feeding.
Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content.
CHU de Bordeaux - Hôpital des Enfants
Bordeaux, France
Hôpital Couple Enfant
Grenoble, France
Hôpital Nord
Marseille, France
Maternité Régionale Universitaire A. Pinard - CHRU Nancy
Nancy, France
Hôpital femme-maternité
Nantes, France
CHR Orléans - Hôpital de la Source
Orléans, France
Centre Hospitalier de Pau
Pau, France
Feeding tolerance
The primary objective is to demonstrate non-inferiority in feeding tolerance (defined as number of days to reach full enteral feeding) of preterm infants receiving a liquid supplement composed of 2 HMOs compared to those receiving the placebo.
Time frame: 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)
Length
Through standardized measurement for neonates
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Head circumference
Through standardized measurement for neonates
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Weight gain
Through standardized measurement for neonates
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Assessment of infant illnesses and infections
Through Adverse Event reporting
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Tolerance to feeding regimen
Through neonatal unit records
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Physical signs of gastrointestinal tolerance
Through neonatal unit records
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Breast milk composition such as energy, carbohydrate, proteins and fats using mid-infrared transmission methods
Macro and micro nutrients
Time frame: Change from enrolment (baseline) (if feasible) until FEF Day 21, average of 5 weeks
Standard Adverse Event reporting for safety assessment
Through investigator-confirmed Adverse Event reporting
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Fecal microbiota composition and diversity
Fecal microbiota composition and diversity will be assessed using next generation shotgun metagenomics sequencing to provide taxonomic composition and diversity metrics. Quantifiable changes from baseline and between feeding groups in absolute concentrations of bifidobacteria will be assessed using quantifiable polymerase chain reaction
Time frame: Change from enrolment (baseline) through two-months corrected age visit
Fecal metabolic profile
Measures of fecal metabolism will include fecal power of hydrogen (pH) and fecal organic acids (including lactate, propionate, butyrate, acetate, isobutyrate, isovalerate, valerate, formic acid, hexanoic acid, caprylic acid, capric acid, pelargonic acid, undecanoic acid, dodecanoic acid and total fecal organic acids).
Time frame: Change from enrolment (baseline) through two-months corrected age visit
Markers for gut health, gut maturation and immune status
Markers for gut health, gut maturation and immune status will be assessed through measures of: Fecal level of calprotectin, alpha 1 antitrypsin, pancreatic elastase, human beta-defensin 2 , secretory immunoglobulin A, Plasma level of citrulline and twenty four additional Amino Acids Urinary levels of intestinal fatty acid binding protein
Time frame: Change from enrolment (baseline) (if feasible) until FEF Day 21
Early life development outcomes
Aligned with standard routine care, post-discharge clinical assessments of preterm infants include clinically relevant events since last visit, feeding practice (complementary feeding, adequate food intake), Gastrointestinal-related symptoms (sleep, crying), somatic examination (physical examination of skin, digestion, abdomen, hip), Neurosensory Examination (hearing / visual function, gross motor), Relationship and Communication Development (normal or abnormal communication, neurological or psychomotor examination, relationship / behavior disorders). All clinical assessments will be standardized across sites. Ages and Stages Questionnaire-3 will be administered to parents to assess their report of child's developmental progress based on Communication, Gross Motor, Fine Motor, Problem Solving, and Personal-Social domains.
Time frame: At 12 Months Corrected age Visit, 18 Months Corrected age Visit, and 24 Months Corrected age Visit
Cognitive development outcomes
Will be assessed through the composite scores or scale scores of the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III)
Time frame: 24 Months Corrected age Visit
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.