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NCT Number: NCT03607942

Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants

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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Key information

Conditions

Premature Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - Hôpital des Enfants, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

HMO supplement

Dietary Supplement

HMO supplement will be given three times a day, not mixed with any feeding.

Placebo Comparator

Dietary Supplement

Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content.

Primary outcomes

  1. Feeding tolerance

    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)

    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.

Secondary outcomes

  1. Length

    Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

    Through standardized measurement for neonates

  2. Head circumference

    Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

    Through standardized measurement for neonates

  3. Weight gain

    Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

    Through standardized measurement for neonates

  4. Assessment of infant illnesses and infections

    Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

    Through Adverse Event reporting

  5. Tolerance to feeding regimen

    Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

    Through neonatal unit records

  6. Physical signs of gastrointestinal tolerance

    Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

    Through neonatal unit records

  7. Breast milk composition such as energy, carbohydrate, proteins and fats using mid-infrared transmission methods

    Time frame: Change from enrolment (baseline) (if feasible) until FEF Day 21, average of 5 weeks

    Macro and micro nutrients

  8. Standard Adverse Event reporting for safety assessment

    Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

    Through investigator-confirmed Adverse Event reporting

  9. Fecal microbiota composition and diversity

    Time frame: Change from enrolment (baseline) through two-months corrected age visit

    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

  10. Fecal metabolic profile

    Time frame: Change from enrolment (baseline) through two-months corrected age visit

    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).

  11. Markers for gut health, gut maturation and immune status

    Time frame: Change from enrolment (baseline) (if feasible) until FEF Day 21

    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

  12. Early life development outcomes

    Time frame: At 12 Months Corrected age Visit, 18 Months Corrected age Visit, and 24 Months Corrected age Visit

    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.

  13. Cognitive development outcomes

    Time frame: 24 Months Corrected age Visit

    Will be assessed through the composite scores or scale scores of the Bayley Scales of Infant and Toddler Development - Third Edition (Bayley-III)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Jul 31, 2018
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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