Premature InfantNCT03607942
Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants
A study testing HMO supplement in people with Premature Infant, run by Société des Produits Nestlé (SPN) at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Premature Infant
- What is being tested?
- HMO supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 7 sitesFrance
- Study dates
- 6 Aug 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Bordeaux - Hôpital des Enfants
Bordeaux, 33000
Hôpital Couple Enfant
Grenoble, 38043
Hôpital Nord
Marseille, 13000
Maternité Régionale Universitaire A. Pinard - CHRU Nancy
Nancy, 54035
Hôpital femme-maternité
Nantes, 44093
CHR Orléans - Hôpital de la Source
Orléans, 45100
Centre Hospitalier de Pau
Pau, 64046
About this study
Official title: Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial
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.
- Conditions
- Premature Infant
- Being tested
- HMO supplement, Placebo comparator
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HMO supplementDietary supplement
HMO supplement will be given three times a day, not mixed with any feeding.
Placebo comparatorDietary supplement
Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Formula | Experimental | The experimental group will receive a liquid supplement containing 2 specific HMOs Receives: Dietary Supplement: HMO supplement |
| Control Formula | Placebo comparator | The control group will receive a liquid placebo Receives: Dietary Supplement: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (13)
Length
Through standardized measurement for neonates
Measured: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Head circumference
Through standardized measurement for neonates
Measured: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Weight gain
Through standardized measurement for neonates
Measured: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Assessment of infant illnesses and infections
Through Adverse Event reporting
Measured: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Tolerance to feeding regimen
Through neonatal unit records
Measured: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Physical signs of gastrointestinal tolerance
Through neonatal unit records
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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)
Measured: 24 Months Corrected age Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start6 Aug 2018
- Primary completion30 Oct 2020
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Michel Hascoët, Prof, Study director, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607942
- Sponsor's protocol ID
- 17.02.INF
- Status last verified
- Mar 2023
- First submitted
- 5 Apr 2018
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants: a Double-blind, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03607942
- Acronym / sponsor ID
- 17.02.INF
- Conditions
- Premature Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Formula | Experimental | Dietary Supplement: HMO supplementThe experimental group will receive a liquid supplement containing 2 specific HMOs |
| Control Formula | Placebo comparator | Dietary Supplement: Placebo comparatorThe control group will receive a liquid placebo |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HMO supplementHMO supplement will be given three times a day, not mixed with any feeding. | Dietary supplement | Experimental Formula |
| Placebo comparatorControl product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content. | Dietary supplement | Control Formula |
Primary outcome
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.
13 secondary outcomes
Length
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Head circumference
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Weight gain
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Assessment of infant illnesses and infections
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Tolerance to feeding regimen
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Physical signs of gastrointestinal tolerance
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
Time frame: Change from enrolment (baseline) (if feasible) until FEF Day 21, average of 5 weeks
Standard Adverse Event reporting for safety assessment
Time frame: Change from enrolment (baseline) (if feasible) through study completion, average of 4 months
Fecal microbiota composition and diversity
Time frame: Change from enrolment (baseline) through two-months corrected age visit
Fecal metabolic profile
Time frame: Change from enrolment (baseline) through two-months corrected age visit
Markers for gut health, gut maturation and immune status
Time frame: Change from enrolment (baseline) (if feasible) until FEF Day 21
Early life development outcomes
Time frame: At 12 Months Corrected age Visit, 18 Months Corrected age Visit, and 24 Months Corrected age Visit
Cognitive development outcomes
Time frame: 24 Months Corrected age Visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel Hascoët, Prof study director
CHRU Nancy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HMO supplement in people with Premature Infant, run by Société des Produits Nestlé (SPN) at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.