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

December 6, 2022 updated by: Jean-Michel Lecerf, Institut Pasteur de Lille

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lille, France, 59000
        • Institut Pasteur de Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1 to 21-days old child

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2016

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

December 16, 2016

First Submitted That Met QC Criteria

December 16, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 6, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-A01403-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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