Child DevelopmentBABYMILKNCT02997826
Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months.
A study testing Infantil formula in people with Child Development, run by Institut Pasteur de Lille at 1 site in France.
Trial summary
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Read more about this study
- Who is it for?
- Ages 1 day to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Infantil formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2016to 30 Oct 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 1 day to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0 to 3 weeks
- Infants whose mothers do not wish or can not breastfeed for personal or medical reasons
- Child followed by a general practitioner or pediatrician
- Informed consent form signed by the legal representatives of the subject
- Commitment of legal representatives to follow the constraints generated by the study
- Insured
Who cannot join
- Nursing mother
- Infant born prematurely before 37 weeks of amenorrhea
- Child allergic to cow's milk proteins
- Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
- Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
- Incapacity for the legal representative(s) to understand or adhere to the protocol
Show all 14Show fewer
- Mother smoking or vapoting during pregnancy;
- Subject involved in another clinical study or in an exclusion period from another study
- Legal representatives deprived of liberty
- Legal representatives in a position to judicial protection
- Weight of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
- Subject height according to age and sex, not between the 3rd and the 97th percentile of the WHO Child Growth Standards
- BMI of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
- Head circumference of the subject according to age and sex, not included between the 3rd and the 97th percentile of the WHO Child Growth Standards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Infant Formula Consumption on Infant Growth From 0 to 6 Months
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.
The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.
Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).
- Conditions
- Child Development
- Being tested
- Infantil formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infantil formulaOther
| Study group | Role | What they receive |
|---|---|---|
| 1 to 21-days old child | Other | Not described Receives: Other: Infantil formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight evolution of infants fed with infant formula
Measured: from 0 to 3 months
Secondary outcomes (3)
Weight evolution of infants fed with infant formula
Measured: from 0 to 6 months
Height evolution of infants fed with infant formula
Measured: from 0 to 6 months
Head circumference evolution of infants fed with infant formula
Measured: from 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study start14 Nov 2016
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur de Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel Lecerf, Institut Pasteur de Lille
- Investigators
- Jean-Michel Lecerf, MD, Principal investigator, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997826
- Sponsor's protocol ID
- 2016-A01403-48
- Acronym
- BABYMILK
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2016
- Last updated
- 8 Dec 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infant Formula Consumption on Infant Growth From 0 to 6 Months
- ClinicalTrials.gov ID
- NCT02997826
- Acronym / sponsor ID
- BABYMILK / 2016-A01403-48
- Conditions
- Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institut Pasteur de LilleUniversity, hospital or other
- Study start
- 14 Nov 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 20 Dec 2016 (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.
From birth to 5 months, milk is the essential and unique food of the newborn. The French National Nutrition Program (PNNS) recommends exclusive breastfeeding "up to 6 months and at least 4 months for a healthy benefit". However, only 36% of infants 0-6 months of age are exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in the first few months of life. This decision may be a personal choice or be imposed by pathophysiological situations.
The nutritional requirements of the infant are specific, which implies adequate nutrition. Infant formulas and follow-up formulas are therefore complex products, specially developed for a group of vulnerable consumers. In fact, the compositional and information requirements for infant formula are highly regulated.
Even clinical studies are not required to market an infant formula, it is important to obtain objective date on infant growth. Therefore, this study proposes to evaluate the effect of the consumption of an infant formula on the growth of infants from 0 to 6 months in comparison with the growth curves of the World Health Organization (WHO).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 to 21-days old child | Other | Other: Infantil formula |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 0 to 3 weeks
- Infants whose mothers do not wish or can not breastfeed for personal or medical reasons
- Child followed by a general practitioner or pediatrician
- Informed consent form signed by the legal representatives of the subject
- Commitment of legal representatives to follow the constraints generated by the study
Key exclusion criteria (14 listed)
- Nursing mother
- Infant born prematurely before 37 weeks of amenorrhea
- Child allergic to cow's milk proteins
- Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);
- Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma, diabetes, digestive, renal, cardiac or haematological diseases);
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 |
|---|---|---|
| Infantil formula | Other | 1 to 21-days old child |
Primary outcome
Weight evolution of infants fed with infant formula
Time frame: from 0 to 3 months
3 secondary outcomes
Weight evolution of infants fed with infant formula
Time frame: from 0 to 6 months
Height evolution of infants fed with infant formula
Time frame: from 0 to 6 months
Head circumference evolution of infants fed with infant formula
Time frame: from 0 to 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 8 Dec 2022.
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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.
Jean-Michel Lecerf, MD principal investigator
Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infantil formula in people with Child Development, run by Institut Pasteur de Lille at 1 site in France.
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 14 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 8 Dec 2022. 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 France. 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 evolution of infants fed with infant formula (time frame: from 0 to 3 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 8 Dec 2022.