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

NCT02997826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-12-08

No results posted yet for this study

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

Interventions

OTHER

Infantil formula

Sponsors & Collaborators

  • Institut Pasteur de Lille

    lead OTHER

Principal Investigators

  • Jean-Michel Lecerf, MD · Institut Pasteur de Lille

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
21 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-14
Primary Completion
2018-10-30
Completion
2018-10-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02997826 on ClinicalTrials.gov