Dietary ModificationNCT01585142
Growth of Infants Fed With BabyNes System
A study testing Test formula in people with Dietary Modification, run by Société des Produits Nestlé (SPN) at 4 sites in Switzerland.
Trial summary
The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- Test formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesSwitzerland
- Study dates
- Apr 2012to Jul 2014
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn
- Full term newborn (≥ 37 weeks gestation)
- Birth weight ≥ 2500 g and ≤ 4500 g
- Newborn from birth to 14 days of age at the time of enrollment
- The newborn's mother has voluntarily elected to exclusively formula feed her newborn
- Having obtained his/her signed legal representative's informed consentHealthy newborn infant
Who cannot join
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
- Newborn whose mother's BMI was abnormal (<18.5 or >30kg/m2) at start of pregnancy
- Newborn whose mother has diabetes of type-1 or type-2
- Newborn whose mother has a chronic infectious disease
- Newborn whose parents / caregivers cannot be expected to comply with treatment
- Newborn currently participating in another nutritional interventional clinical trial (except for vaccination studies)
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Universitäts-Kinderspital beider Basel (UKBB)
Basel, 4031
Hôpital des enfants
Geneva, 1205
CHUV Unité de Gastroentérologie Pédiatrique DMCP-BH11
Lausanne, 1011
Pädiatrische Gastroenterologie und Hepatologie Kinderspital
Lucerne, 6000
About this study
Official title: Assessment of Growth of Infants Fed With BabyNes System (Single-serve Formulas, Adaptative System)
The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life.
- Conditions
- Dietary Modification
- Being tested
- Test formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test formulaOther
Also called BabyNes System
Infant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition
| Study group | Role | What they receive |
|---|---|---|
| BabyNes system formula | Experimental | Not described Receives: Other: Test formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
z-score weight-for-age (WHO Child Growth Standards)
Measured: 4 months
Secondary outcomes (3)
Growth
BMI for age z-scores, weight for length z-scores, length for age z-scores, head circumference for age z-scores
Measured: 12 months
Compliance
Volume of formula intake
Measured: 12 months
Morbidity
Number of infants with adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johannes Spalinger, Dr med., Principal investigator, Pädiatrische Gastroenterologie und Hepatologie Kinderspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01585142
- Sponsor's protocol ID
- 11.18.INF
- Status last verified
- Jan 2015
- First submitted
- 24 Apr 2012
- Last updated
- 16 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Growth of Infants Fed With BabyNes System (Single-serve Formulas, Adaptative System)
- ClinicalTrials.gov ID
- NCT01585142
- Acronym / sponsor ID
- 11.18.INF
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Apr 2012 (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.
The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BabyNes system formula | Experimental | Other: Test formula |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy newborn
- Full term newborn (≥ 37 weeks gestation)
- Birth weight ≥ 2500 g and ≤ 4500 g
- Newborn from birth to 14 days of age at the time of enrollment
- The newborn's mother has voluntarily elected to exclusively formula feed her newborn
Key exclusion criteria (6 listed)
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency)
- Newborn whose mother's BMI was abnormal (<18.5 or >30kg/m2) at start of pregnancy
- Newborn whose mother has diabetes of type-1 or type-2
- Newborn whose mother has a chronic infectious disease
- Newborn whose parents / caregivers cannot be expected to comply with treatment
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 |
|---|---|---|
| Test formulaAlso: BabyNes SystemInfant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition | Other | BabyNes system formula |
Primary outcome
z-score weight-for-age (WHO Child Growth Standards)
Time frame: 4 months
3 secondary outcomes
Growth
Time frame: 12 months
Compliance
Time frame: 12 months
Morbidity
Time frame: 12 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 2015.
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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.
Johannes Spalinger, Dr med. principal investigator
Pädiatrische Gastroenterologie und Hepatologie Kinderspital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test formula in people with Dietary Modification, run by Société des Produits Nestlé (SPN) at 4 sites in Switzerland.
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 6 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 2015. 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 Switzerland. 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?
z-score weight-for-age (WHO Child Growth Standards) (time frame: 4 months). 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 2015.