Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months.

Study Overview
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Brief Summary
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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).

Official Title
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Effect of Infant Formula Consumption on Infant Growth From 0 to 6 Months

Conditions
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Child Development

Intervention / Treatment
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* Other: Infantil formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 21 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1 to 21-days old child<br> | Other: Infantil formula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight evolution of infants fed with infant formula |  | from 0 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight evolution of infants fed with infant formula |  | from 0 to 6 months | 
| Height evolution of infants fed with infant formula |  | from 0 to 6 months | 
| Head circumference evolution of infants fed with infant formula |  | from 0 to 6 months |