Pre-term InfantNCT04639518
Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants
A study testing Preterm formulas with HMO and Preterm formulas without HMO in people with Pre-term Infant, run by Société des Produits Nestlé (SPN) at 4 sites in 3 countries.
Trial summary
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs). Read more about this study
- Who is it for?
- Ages Up to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Pre-term Infant
- What is being tested?
- Preterm formulas with HMO and Preterm formulas without HMO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Sep 2020to 28 Apr 2025
- 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 10 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
- Infants' birth weight ≤1500 g and AGA.
- Infant's gestational age < 37 weeks.
- Infant is clinically stable and does not have deteriorating respiratory function after birth.
- Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.
Who cannot join
- Parent(s) not willing / not able to comply with the requirements of study protocol.
- Infant is experiencing early onset sepsis.
- Major congenital or chromosomal abnormality known to affect growth.
- Liver failure.
- Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).
- Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk.
- Infant's participation in another interventional clinical trial.
- Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Slovakia2 sites
Univerzitna nemocnica Martin
Martin, 3659
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34
About this study
Official title: Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants: a Multi-centered, Open-label Clinical Trial
This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).
Read the detailed description
This is a multi-center, open-label trial to be conducted in up to 70 pre-term infants in order to evaluate the safety and suitability of two feeding systems as they would typically be used in the neonatal care unit. Growth (in comparison to recommended growth goals), feeding tolerance, biochemical parameters, and adverse event reporting will be evaluated.
The two feeding systems will be tested in two sub-studies to be conducted sequentially: sub-study 1 will evaluate a two-staged feeding system with HMOs in up to 35 pre-term infants; sub-study 2 will evaluate a two-staged feeding system without HMOs in up to 35 pre-term infants.
A follow up period from 12 to 24 months have been added to the study protocol, to assess the neurocognitive development of the subjects during this period.
- Conditions
- Pre-term Infant
- Being tested
- Preterm formulas with HMO, Preterm formulas without HMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm formulas with HMOOther
Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.
Preterm formulas without HMOOther
Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1 | Experimental | Pre-term formulas with HMO Receives: Other: Preterm formulas with HMO |
| Sub-study 2 | Experimental | Pre-term formulas without HMO Receives: Other: Preterm formulas without HMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth
Weight-adjusted weight gain (g/kg/day)
Measured: From FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier
Secondary outcomes (27)
Weight at other time points
Changes in weight gain (g/day and g/kg/day)
Measured: From Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Other growth parameter (length)
Change in length (cm/week)
Measured: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Other growth parameter (head circumference)
Change in head circumference (cm/week)
Measured: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Anthropometric z-scores for weight, length and head circumference
Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed
Measured: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Feeding intake at neonatal unit
Neonatal unit feeding questionnaire capturing timing, type, rate and amount of feeding (parenteral \& enteral), gastric residual volumes, number of missed feedings
Measured: Baseline + weekly over 3 consecutive days starting on pre-FEF Day1 + weekly over 3 consecutive days starting on FEF Day1 until Neonatal Unit Discharge (on average 7 weeks after birth)
Stool frequency at neonatal unit
Stool frequency (range from 0-20 times a day) collected via neonatal unit questionnaire
Measured: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Stool consistency at neonatal unit
Stool consistency (watery, mushy soft, runny, formed, hard) collected via neonatal unit questionnaire
Measured: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Bloody stools at neonatal unit
Bloody stools (yes or no) collected via neonatal unit questionnaire
Measured: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
GI symptoms at neonatal unit
GI symptoms (incidence of abdominal distention, regurgitation, spitting and vomiting) collected via neonatal unit questionnaire
Measured: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Feeding intake after discharge
Parent-reported 3-Day Intake Diary capturing the total number of bottles of formula and approximate volumes consumed per day
Measured: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
Stool frequency after discharge
Stool frequency captured via parent-reported 3-Day Intake Diary
Measured: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
Stool consistency after discharge
Stool frequency captured via parent-reported 3-Day Intake Diary
Measured: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
GI symptoms after discharge
GI symptoms (such as presence of stomach ballooning, bloody stools, regurgitation, spitting-up and vomiting) captured via parent-reported 3-Day Intake Diary
Measured: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
GI-related behaviors after discharge
GI-related behaviors (such as crying and sleep quality) captured via parent-reported 3-Day Intake Diary
Measured: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
Serum biomarkers for protein status
Serum albumin and blood urea nitrogen (BUN)
Measured: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD
Serum biomarkers for bone health
Serum P, alkaline phosphatase, calcium and creatinine
Measured: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD
Urine biomarkers for bone health
Urinary Ca, P and creatinine
Measured: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD
Vitamin D
Vitamin D
Measured: FEF Day 1, Neonatal Unit Discharge and at 60 days PD
Fecal microbiota
Fecal microbiota composition, diversity and metabolism markers (SCFAs)
Measured: Baseline, FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, at 30 day-PD and 60 days PD
Fecal markers for gut health / maturation and immune status
Fecal levels of calprotectin, alpha 1 antitrypsin, pancreatic elastase (i.e. chymotrypsin-like elastase family, member 3B (CELA3B)), Human beta-defensin 2 (HBD2) and secretory IgA
Measured: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD
Urine markers for gut health / maturation and immune status
Urinary level (spot urine sample) of intestinal fatty acid binding protein (iFABP)
Measured: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD
AE reporting
Number of AEs through investigator-confirmed AE reporting
Measured: From the time the mother has consented to the infant's participation in the study until the 60 days PD visit
Bayley-III scores
Bayley scales of Infants and Toddler development - 3rd edition
Measured: At 12, 18, and 24 months
Developmental Milestone scores
Parent-reported achievements of specific-age appropriate milestones (yes/no reponses to child performing specific milestones or not)
Measured: At 12, 18, and 24 months
Child temperament scores
Parent-reported child temperament questionnaire
Measured: At 12, 18, and 24 months
Number of healthcare usage
Retrospective paret-reported recall of the number of healthcare usage and hospitalizations
Measured: At 12, 18, and 24 months
Feeding patterns
Feeding practice outcomes collected retrospectively at each visit via a parent-reported questionnaire related to breastfeeding duration, prevalence of formula feeding, and age at initiation of complementary feeding
Measured: At 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start10 Sep 2020
- Primary completion30 Jun 2024
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-term 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two sequential sub-studies
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
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
- NCT04639518
- Sponsor's protocol ID
- 18.09.INF
- Status last verified
- Jan 2026
- First submitted
- 22 Oct 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants: a Multi-centered, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT04639518
- Acronym / sponsor ID
- 18.09.INF
- Conditions
- Pre-term Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 20 Nov 2020 (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 an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).
Detailed description
This is a multi-center, open-label trial to be conducted in up to 70 pre-term infants in order to evaluate the safety and suitability of two feeding systems as they would typically be used in the neonatal care unit. Growth (in comparison to recommended growth goals), feeding tolerance, biochemical parameters, and adverse event reporting will be evaluated.
The two feeding systems will be tested in two sub-studies to be conducted sequentially: sub-study 1 will evaluate a two-staged feeding system with HMOs in up to 35 pre-term infants; sub-study 2 will evaluate a two-staged feeding system without HMOs in up to 35 pre-term infants.
A follow up period from 12 to 24 months have been added to the study protocol, to assess the neurocognitive development of the subjects during this period.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two sequential sub-studies
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1 | Experimental | Other: Preterm formulas with HMOPre-term formulas with HMO |
| Sub-study 2 | Experimental | Other: Preterm formulas without HMOPre-term formulas without HMO |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
- Infants' birth weight ≤1500 g and AGA.
- Infant's gestational age < 37 weeks.
- Infant is clinically stable and does not have deteriorating respiratory function after birth.
- Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.
Key exclusion criteria (8 listed)
- Parent(s) not willing / not able to comply with the requirements of study protocol.
- Infant is experiencing early onset sepsis.
- Major congenital or chromosomal abnormality known to affect growth.
- Liver failure.
- Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).
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 |
|---|---|---|
| Preterm formulas with HMOPreterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge. | Other | Sub-study 1 |
| Preterm formulas without HMOPreterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge. | Other | Sub-study 2 |
Primary outcome
Growth
Time frame: From FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier
Weight-adjusted weight gain (g/kg/day)
27 secondary outcomes
Weight at other time points
Time frame: From Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Other growth parameter (length)
Time frame: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Other growth parameter (head circumference)
Time frame: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Anthropometric z-scores for weight, length and head circumference
Time frame: From Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth), at 30- and 60-days PD, and at 12, 18, and 24 months
Feeding intake at neonatal unit
Time frame: Baseline + weekly over 3 consecutive days starting on pre-FEF Day1 + weekly over 3 consecutive days starting on FEF Day1 until Neonatal Unit Discharge (on average 7 weeks after birth)
Stool frequency at neonatal unit
Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Stool consistency at neonatal unit
Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Bloody stools at neonatal unit
Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
GI symptoms at neonatal unit
Time frame: Weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Feeding intake after discharge
Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
Stool frequency after discharge
Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
Stool consistency after discharge
Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
GI symptoms after discharge
Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
GI-related behaviors after discharge
Time frame: 3 consecutive days just prior to the 30-day PD and 60-day PD visits
Serum biomarkers for protein status
Time frame: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD
Serum biomarkers for bone health
Time frame: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD
Urine biomarkers for bone health
Time frame: At Baseline (if possible), pre-FEF Day 1, then weekly pre-FEF Days 7, 14, etc. and FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, and at 60 days PD
Vitamin D
Time frame: FEF Day 1, Neonatal Unit Discharge and at 60 days PD
Fecal microbiota
Time frame: Baseline, FEF Day 1, then weekly on FEF Days 7, 14, 21, until Neonatal Unit Discharge, at 30 day-PD and 60 days PD
Fecal markers for gut health / maturation and immune status
Time frame: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD
Urine markers for gut health / maturation and immune status
Time frame: Baseline (if feasible), FEF Day 1, Day 21, Neonatal Unit Discharge, 30 day-PD and 60 day-PD
AE reporting
Time frame: From the time the mother has consented to the infant's participation in the study until the 60 days PD visit
Bayley-III scores
Time frame: At 12, 18, and 24 months
Developmental Milestone scores
Time frame: At 12, 18, and 24 months
Child temperament scores
Time frame: At 12, 18, and 24 months
Number of healthcare usage
Time frame: At 12, 18, and 24 months
Feeding patterns
Time frame: At 12, 18, and 24 months
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 16 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preterm formulas with HMO and Preterm formulas without HMO in people with Pre-term Infant, run by Société des Produits Nestlé (SPN) at 4 sites in 3 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 5 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Slovakia, Germany, Poland. 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?
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?
Growth (time frame: From FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier). 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 16 Jan 2026.