GrowthNCT02490852
Study of Nutritional Suitability of a New Infant Formula for Term Infants
A study testing Investigational infant formula, Active Comparator: Commercially available Infant formula and Active Comparator: Human milk in people with Growth, run by Ausnutria Hyproca B.V. at 18 sites in 4 countries.
Trial summary
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference. Read more about this study
- Who is it for?
- Ages Up to 13 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Investigational infant formula, Active Comparator: Commercially available Infant formula and Active Comparator: Human milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Aug 2015to 22 Aug 2018
- 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 13 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy full term infant (37-42 weeks of gestational age)
- Birth weight 2,500 to 4,500 g
- Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
- Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
- Informed consent signed by parent(s)/caregiver(s)
Who cannot join
- Congenital illness or malformation that may affect infant feeding or normal growth
- Gastrointestinal disorders
- Suspected or known allergy to milk protein for formula groups
- Known food allergies in parents or siblings for formula groups
- Multiples
- Readmission to hospital for longer than 3 days for another reason than hyperbilirubinemia prior to enrollment
- Infant participating in another clinical study
- Infant's family unable to comply with the protocol according to the investigators's assessment
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Croatia8 sites
Study site
Đakovo
Study site
Dubrovnik
Study site
Kutina
Study site
Split
Study site
Vukovar
Study site
Zadar
Study site
Zagreb
Study site
Zaprešić
Germany7 sites
Study site
Bramsche
Study site
Hamm
Study site
Herford
Study site
Mannheim
Study site
Mönchengladbach
Study site
Wesel
Study site
Wuppertal
About this study
This is a growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.
- Conditions
- Growth
- Being tested
- Investigational infant formula, Active Comparator: Commercially available Infant formula, Active Comparator: Human milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational infant formulaOther
fed ad libitum
Active Comparator: Commercially available Infant formulaOther
fed ad libitum
Active Comparator: Human milkOther
fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Investigational Infant formula | Experimental | Healthy term infants fed exclusively the investigational Infant Formula Receives: Other: Investigational infant formula |
| Commercially available Infant formula | Active comparator | Healthy term infants fed exclusively a commercially available Infant Formula Receives: Other: Active Comparator: Commercially available Infant formula |
| Human milk | Active comparator | Healthy term infants fed exclusively human milk Receives: Other: Active Comparator: Human milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion22 Aug 2018
- Study completion22 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ausnutria Hyproca B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Falco Panzer, Dr. Med., Principal investigator, Kinderärztliche Gemeinschaftspraxis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490852
- Sponsor's protocol ID
- AUS/015513
- Status last verified
- Nov 2018
- First submitted
- 29 Jun 2015
- Last updated
- 21 May 2019
- Results posted
- No
Publications
van Lee L, Meijer-Krommenhoek Y, He T, van der Zee L, Verkade H. Sleep duration among breastfed, goat milk-based or cow's milk-based infant formula-fed infants: Post hoc analyses from a double-blind RCT. J Pediatr Gastroenterol Nutr. 2025 Mar;80(3):482-489. doi: 10.1002/jpn3.12436. Epub 2024 Dec 19.
PubMed 39698907
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nutritional Suitability of a New Infant Formula for Term Infants
- ClinicalTrials.gov ID
- NCT02490852
- Acronym / sponsor ID
- AUS/015513
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Ausnutria Hyproca B.V.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- 22 Aug 2018 (actual)
- Study completion
- 22 Aug 2018 (actual)
- First posted
- 7 Jul 2015 (estimated)
- 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 growth study of full-term infants. The growth of infants fed the investigational formula will be compared with infants fed a control formula. A breastfeeding arm will be used as reference.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational Infant formula | Experimental | Other: Investigational infant formulaHealthy term infants fed exclusively the investigational Infant Formula |
| Commercially available Infant formula | Active comparator | Other: Active Comparator: Commercially available Infant formulaHealthy term infants fed exclusively a commercially available Infant Formula |
| Human milk | Active comparator | Other: Active Comparator: Human milkHealthy term infants fed exclusively human milk |
Who may qualify
- Ages
- Up to 13 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy full term infant (37-42 weeks of gestational age)
- Birth weight 2,500 to 4,500 g
- Infant's mother willing and able to exclusively breast feed or infant's parent(s)/caregiver(s) willing to exclusively use randomized infant formula during study participation
- Parent(s)/caregiver(s) able to attend visits and willing to complete the subject diary
- Informed consent signed by parent(s)/caregiver(s)
Key exclusion criteria (8 listed)
- Congenital illness or malformation that may affect infant feeding or normal growth
- Gastrointestinal disorders
- Suspected or known allergy to milk protein for formula groups
- Known food allergies in parents or siblings for formula groups
- Multiples
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 |
|---|---|---|
| Investigational infant formulafed ad libitum | Other | Investigational Infant formula |
| Active Comparator: Commercially available Infant formulafed ad libitum | Other | Commercially available Infant formula |
| Active Comparator: Human milkfed ad libitum | Other | Human milk |
Primary outcome
Weight gain
Time frame: 16 weeks
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 May 2019.
- Derived from this study: PubMed 39698907van Lee L, Meijer-Krommenhoek Y, He T, van der Zee L, Verkade H. Sleep duration among breastfed, goat milk-based or cow's milk-based infant formula-fed infants: Post hoc analyses from a double-blind RCT. J Pediatr Gastroenterol Nutr. 2025 Mar;80(3):482-489. doi: 10.1002/jpn3.12436. Epub 2024 Dec 19.
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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.
Falco Panzer, Dr. Med. principal investigator
Kinderärztliche Gemeinschaftspraxis
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational infant formula, Active Comparator: Commercially available Infant formula and Active Comparator: Human milk in people with Growth, run by Ausnutria Hyproca B.V. at 18 sites in 4 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 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Croatia, Germany, Spain, 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?
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?
Weight gain (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490852, which also lists 1 linked publication.
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 May 2019.