Premature InfantNCT06212427
Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)
A study testing HMO supplement in people with Premature Infant and Low Birthweight Infant, run by Société des Produits Nestlé (SPN) at 6 sites in 2 countries.
Trial summary
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting. Read more about this study
- Who is it for?
- Ages 0 to 14 days
- Conditions the study is for
- Premature Infant, Low Birthweight Infant
- What is being tested?
- HMO supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 20 Nov 2023to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR], if applicable)
- Infant's parent(s)/LAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol
- Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
- Infant birth weight ≤ 2500g
- Infant postnatal age ≤ 14 days
- Infant has tolerated trophic feeds (e.g., 10-15 mL/kg/day) for at least 24 hours but has not yet reached full enteral feeding
Who cannot join
- Infant is clinically unstable, for example:
- Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP < 5th percentile for age for at least three hours), or is receiving vasopressor drugs
- Infant has received an exchange transfusion within the past 48 hours
- Infant has had an episode of severe asphyxia at birth (PH less than 7.0)
- Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)
- Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
- Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
- Participation in another interventional clinical study that may interfere with the results of this study
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Germany5 sites, 4 recruiting
- Recruiting
Evangelisches Waldkrankenhaus Spandau
Berlin-Spandau
Lindsey Otten, Dr., lindsey.otten@jsd.de
Frank Jochum, Dr.
- Recruiting
Kinderklinik Darmstadt
Darmstadt
Andrea Reichl, Andrea.Reichl@kinderkliniken.de
Thomas Weiss, Dr.
- Withdrawn
Wilhelmstift Hamburg
Hamburg
- Recruiting
Uniklinik Heidelberg
Heidelberg
Suzanne Klein, Susanne.Klein@med.uni-heidelberg.de
Christian Gille, Prof.
- Recruiting
Klinikum Nürnberg
Nuremberg, 90419
Mara Cabrera-Diaz, Mara.CabreraDiaz@klinikum-nuernberg.de
Christian Fusch, Prof.
Austria1 site, 1 recruiting
- Recruiting
Kepler Universitätsklinikum Linz
Linz, 4020
Melanie Gsollpointner
Judith Rittenschober-Boehm, Prof.
About this study
Official title: Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.
A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.
- Conditions
- Premature Infant, Low Birthweight Infant
- Being tested
- HMO supplement
- Keywords
- Human Milk Oligosaccharides, Feeding tolerance, Growth
- 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
Liquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding.
| Study group | Role | What they receive |
|---|---|---|
| HMO supplement | Other | Not described Receives: Dietary Supplement: HMO supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding tolerance
Time to reach full enteral feeding rate of 150 mL/kg/day
Measured: From birth until achievement of full enteral feeding (1 to 3 weeks)
Feeding tolerance
Time to reach cessation of parenteral feeding
Measured: From birth until achievement of full enteral feeding (1 to 3 weeks)
Secondary outcomes (5)
Gastrointestinal tolerance
Through data collected from neonatal unit records
Measured: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Weight gain
Measured in kilograms per day
Measured: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Length gain
Measured in centimeters per week
Measured: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Head circumference gain
Measured in centimeters per week
Measured: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
Type, incidence, severity, seriousness, and relation to HMO supplement consumption as well as concomitant medications and non-pharmacological treatments.
The incidence of specific illnesses of interest
- Necrotizing enterocolitis b Confirmed or suspected late-onset sepsis c. Bronchopulmonary dysplasia d. Retinopathy of prematurity
Measured: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start20 Nov 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212427
- Sponsor's protocol ID
- 2211INF
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study
- ClinicalTrials.gov ID
- NCT06212427
- Acronym / sponsor ID
- 2211INF
- Conditions
- Premature Infant, Low Birthweight Infant
- Keywords
- Human Milk Oligosaccharides, Feeding tolerance, Growth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 18 Jan 2024 (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.
The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose [2'FL] and lacto-N-neotetraose [LNnT], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.
A comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HMO supplement | Other | Dietary Supplement: HMO supplement |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Written informed consent has been obtained from at least one parent (or other legally acceptable representative [LAR], if applicable)
- Infant's parent(s)/LAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol
- Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound
- Infant birth weight ≤ 2500g
- Infant postnatal age ≤ 14 days
Key exclusion criteria (8 listed)
- Infant is clinically unstable, for example:
- Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)
- Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
- Participation in another interventional clinical study that may interfere with the results of this study
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 supplementLiquid supplement containing 2 specific HMOs. Supplement will be given 3-4 times a day, not mixed with any feeding. | Dietary supplement | HMO supplement |
Primary outcome
Feeding tolerance
Time frame: From birth until achievement of full enteral feeding (1 to 3 weeks)
Time to reach full enteral feeding rate of 150 mL/kg/day
Feeding tolerance
Time frame: From birth until achievement of full enteral feeding (1 to 3 weeks)
Time to reach cessation of parenteral feeding
5 secondary outcomes
Gastrointestinal tolerance
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Weight gain
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Length gain
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Head circumference gain
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Safety via reporting of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From enrollment (baseline) until NICU discharge (V5), assessed up to 13 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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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.
6 sites in 2 countries: 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 and Low Birthweight Infant, run by Société des Produits Nestlé (SPN) at 6 sites in 2 countries.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Austria. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inez Sroda (+41217858259, Inez.Sroda@rd.nestle.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding tolerance (time frame: From birth until achievement of full enteral feeding (1 to 3 weeks)). The study lists 2 primary outcomes in all. 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 8 Dec 2025.