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

NCT ID: NCT02997826

Last Updated: 2022-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-14
• Study Completion Date: 2018-10-30

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1 to 21-days old child

Group Type: OTHER

Infantil formula

Intervention Type: OTHER

Interventions

Infantil formula

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 21 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur de Lille

OTHER

Sponsor Role: lead

Responsible Party

Jean-Michel Lecerf

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean-Michel Lecerf, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Pasteur de Lille

Locations

Institut Pasteur de Lille

Lille, , France

Countries

France

Other Identifiers

2016-A01403-48

Identifier Type: -

Identifier Source: org_study_id