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

Pasteur Institute of Lille (IPL)

Status

Completed

Conditions

Child Development

Treatments

Other: Infantil formula

Study type

Interventional

Funder types

Other

Identifiers

NCT02997826

2016-A01403-48

Details and patient eligibility

About

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).

Enrollment

100 patients

Sex

All

Ages

1 to 21 days old

Volunteers

Accepts Healthy Volunteers

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