GrowthNCT02178514
BabyNes Nutrition System Growth Study
A study testing Formula fed with BabyNes Nutrition System in people with Growth, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial summary
Our main research question is: Do infants fed with BabyNes Nutrition System grow in agreement with the WHO reference? Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic profile closer to breastfed infants? In order to answer both questions an observational trial will be carried out… Read more about this study
- Who is it for?
- Ages Up to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Formula fed with BabyNes Nutrition System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to May 2017
- 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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborns, whose mothers had a normal BMI before pregnancy and no diabetes Healthy newborn infant. Full term infant (≥ 37 weeks gestation and ≤ 42 weeks gestation). Birth weight ≥ 2500 g and ≤ 4500 g. Having obtained his/her signed legal representative's informed consent.
- For BF group:
- Exclusively breastfed since birth, the infant's mother agrees to exclusively breast feed her infant until at least to 4th month.
- Baby is 3 months (3 months ± 7 days) at enrollment.
- For FF group:
- Infant from birth to 21 days of age at the time of enrollment (the 21st day included).
- The infant's mother has voluntarily elected to exclusively formula feed her infant after enrolment.
Who cannot join
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency).
- Newborn whose mother's BMI was abnormal (<18.5 or >23.9) at start of pregnancy. Newborn whose mother has diabetes of type-1 or type-2 or other metabolic disorders.
- 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
1 site in 1 country.
About this study
Official title: Do Infants Fed With BabyNes™ System Grow in Agreement With the World Health Organization (WHO) Reference?
Our main research question is: Do infants fed with BabyNes Nutrition System grow in agreement with the WHO reference?
Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic profile closer to breastfed infants?
In order to answer both questions an observational trial will be carried out for 12 months in order to measure weight and to calculate the weight for age z-scores according to the WHO reference.
A breastfeeding group will be used as reference for the metabolic parameters measured in blood of infants from Chinese background.
The effect of the Babynes formulas will be compared to the metabolic values obtained from this breast-feeding reference group.
Read the detailed description
Design:
12 months-study, with a breastfeeding group for the comparison of metabolic values obtained from a Chinese Reference population.
Number of subjects:
In total, 120 subjects shall be enrolled. 80 subjects will be assigned in formula fed group and 40 subjects to breast feeding group. 20% dropouts are already considered for the sample size of 120.
Product(s) to be tested:
For formula fed group:
- BabyNes 1 months: 0-1 month of age
- BabyNes 2 months: 1-2 months of age
- BabyNes 3-6 months: 3-6 months of age
- BabyNes 7-12 months: 7-12 months of age
For breast feeding group:
- Nan HA 1 once the mothers are no more breastfed from 4 months until 6 months old.
- Nan HA 2 once the mothers are no more breastfed from 6 months until 1 year old.
Amount, dosage, route of administration, duration of study product:
Subjects are included in the study for duration of upto 1 year old of the infant.
For FF group:
From birth to 4 months, they are exclusively fed with the infant formula dispenser (ad libitum).
From 4 months of age they can start diversification but they maintain the adapted infant formula to the age until 12 months.
For BF group:
Mothers are encouraged to exclusively breast feed the infant up to 6 months old or at least until 4 months old. From 4 months of age, or later than 4 months with no more breastfeeding, they can start Nan HA1 / HA 2 (commercial formula) until the age of 12 months. The amount should be suitable for the age and appetite of the infants.
- Conditions
- Growth
- Being tested
- Formula fed with BabyNes Nutrition System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula fed with BabyNes Nutrition SystemOther
| Study group | Role | What they receive |
|---|---|---|
| Formula Feeding group by BabyNes Nutrition System | Experimental | In this arm, all infants will be fed with BabyNes Nutrition System since enrollment until 12 month of age Receives: Other: Formula fed with BabyNes Nutrition System |
| Breastfeeding group | No intervention | used as reference to compare with formula feeding group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in weight-for-age z-score of the WHO Child Growth Standard
Measured: from birth to 4 months of age
Secondary outcomes (3)
the Insulin, C-peptide, IGF-1 leptin and ghrelin level
Measured: at 4 and 12 months
length and head circumference measures
Measured: birth, 1, 2, 4, 6, 9 12 months of age
Body composition: fat mass, lean mass
Measured: 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT02178514
- Sponsor's protocol ID
- 11.20.INF
- Status last verified
- Jan 2018
- First submitted
- 26 Jun 2014
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Infants Fed With BabyNes™ System Grow in Agreement With the World Health Organization (WHO) Reference?
- ClinicalTrials.gov ID
- NCT02178514
- Acronym / sponsor ID
- 11.20.INF
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 Jun 2014 (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.
Our main research question is: Do infants fed with BabyNes Nutrition System grow in agreement with the WHO reference?
Our second question is: Do infants fed with BabyNes Nutrition System have a metabolic profile closer to breastfed infants?
In order to answer both questions an observational trial will be carried out for 12 months in order to measure weight and to calculate the weight for age z-scores according to the WHO reference.
A breastfeeding group will be used as reference for the metabolic parameters measured in blood of infants from Chinese background.
The effect of the Babynes formulas will be compared to the metabolic values obtained from this breast-feeding reference group.
Detailed description
Design:
12 months-study, with a breastfeeding group for the comparison of metabolic values obtained from a Chinese Reference population.
Number of subjects:
In total, 120 subjects shall be enrolled. 80 subjects will be assigned in formula fed group and 40 subjects to breast feeding group. 20% dropouts are already considered for the sample size of 120.
Product(s) to be tested:
For formula fed group:
- BabyNes 1 months: 0-1 month of age
- BabyNes 2 months: 1-2 months of age
- BabyNes 3-6 months: 3-6 months of age
- BabyNes 7-12 months: 7-12 months of age
For breast feeding group:
- Nan HA 1 once the mothers are no more breastfed from 4 months until 6 months old.
- Nan HA 2 once the mothers are no more breastfed from 6 months until 1 year old.
Amount, dosage, route of administration, duration of study product:
Subjects are included in the study for duration of upto 1 year old of the infant.
For FF group:
From birth to 4 months, they are exclusively fed with the infant formula dispenser (ad libitum).
From 4 months of age they can start diversification but they maintain the adapted infant formula to the age until 12 months.
For BF group:
Mothers are encouraged to exclusively breast feed the infant up to 6 months old or at least until 4 months old. From 4 months of age, or later than 4 months with no more breastfeeding, they can start Nan HA1 / HA 2 (commercial formula) until the age of 12 months. The amount should be suitable for the age and appetite of the infants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formula Feeding group by BabyNes Nutrition System | Experimental | Other: Formula fed with BabyNes Nutrition SystemIn this arm, all infants will be fed with BabyNes Nutrition System since enrollment until 12 month of age |
| Breastfeeding group | No intervention | –used as reference to compare with formula feeding group |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy newborns, whose mothers had a normal BMI before pregnancy and no diabetes Healthy newborn infant. Full term infant (≥ 37 weeks gestation and ≤ 42 weeks gestation). Birth weight ≥ 2500 g and ≤ 4500 g. Having obtained his/her signed legal representative's informed consent.
- Exclusively breastfed since birth, the infant's mother agrees to exclusively breast feed her infant until at least to 4th month.
- Baby is 3 months (3 months ± 7 days) at enrollment.
- Infant from birth to 21 days of age at the time of enrollment (the 21st day included).
- The infant's mother has voluntarily elected to exclusively formula feed her infant after enrolment.
Key exclusion criteria (3 listed)
- Congenital illness or malformation that may affect normal growth (especially immunodeficiency).
- Newborn whose mother's BMI was abnormal (<18.5 or >23.9) at start of pregnancy. Newborn whose mother has diabetes of type-1 or type-2 or other metabolic disorders.
- 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).
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 |
|---|---|---|
| Formula fed with BabyNes Nutrition System | Other | Formula Feeding group by BabyNes Nutrition System |
Primary outcome
the change in weight-for-age z-score of the WHO Child Growth Standard
Time frame: from birth to 4 months of age
3 secondary outcomes
the Insulin, C-peptide, IGF-1 leptin and ghrelin level
Time frame: at 4 and 12 months
length and head circumference measures
Time frame: birth, 1, 2, 4, 6, 9 12 months of age
Body composition: fat mass, lean mass
Time frame: 4 months and 6 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 30 Jan 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula fed with BabyNes Nutrition System in people with Growth, run by Société des Produits Nestlé (SPN) at 1 site in China.
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 7 inclusion and 3 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
the change in weight-for-age z-score of the WHO Child Growth Standard (time frame: from birth to 4 months of age). 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 30 Jan 2018.