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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Formula | Experimental | The experimental group will receive a liquid supplement containing 2 specific HMOs |
|
| Control Formula | Placebo Comparator | The control group will receive a liquid placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMO supplement | Dietary Supplement | HMO supplement will be given three times a day, not mixed with any feeding. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Length | Through standardized measurement for neonates | Change from enrolment (baseline) (if feasible) through study completion, average of 4 months |
| Head circumference | Through standardized measurement for neonates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Michel Hascoët, Prof | CHRU Nancy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - Hôpital des Enfants | Bordeaux | 33000 | France | |||
| Hôpital Couple Enfant |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Placebo comparator | Dietary Supplement | Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content. |
|
| Change from enrolment (baseline) (if feasible) through study completion, average of 4 months |
| Weight gain | Through standardized measurement for neonates | Change from enrolment (baseline) (if feasible) through study completion, average of 4 months |
| Assessment of infant illnesses and infections | Through Adverse Event reporting | Change from enrolment (baseline) (if feasible) through study completion, average of 4 months |
| Tolerance to feeding regimen | Through neonatal unit records | Change from enrolment (baseline) (if feasible) through study completion, average of 4 months |
| Physical signs of gastrointestinal tolerance | Through neonatal unit records | 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 | 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 | 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 | 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). | 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 | 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. | 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) | 24 Months Corrected age Visit |
| Grenoble |
| 38043 |
| France |
| Hôpital Nord | Marseille | 13000 | France |
| Maternité Régionale Universitaire A. Pinard - CHRU Nancy | Nancy | 54035 | France |
| Hôpital femme-maternité | Nantes | 44093 | France |
| CHR Orléans - Hôpital de la Source | Orléans | 45100 | France |
| Centre Hospitalier de Pau | Pau | 64046 | France |
| D000091642 | Urogenital Diseases |