- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997826
Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months. (BABYMILK)
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lille, France, 59000
- Institut Pasteur de Lille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: Jean-Michel LECERF, MD, Institut Pasteur de Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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.
Clinical Trials on Child Development
-
Yale UniversityRobinhood Foundation; Adelphi University; Docs for TotsCompletedSocial Skills | Child Behavior | Child Development | Infant DevelopmentUnited States
-
University of Southern CaliforniaSafe Water and AIDS Project (SWAP); Early Childhood Development Network for...RecruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)Active, not recruitingDevelopment Delay | Development, ChildUnited States
-
O-KidiaRecruitingChild Development | Child Development DisorderFrance
-
International Centre for Diarrhoeal Disease Research...UnknownChild Behavior | Child DevelopmentBangladesh
-
The Hospital for Sick ChildrenAga Khan University; March of DimesCompletedChild Development | Child Mortality | Child Morbidity | Child BehaviourPakistan
-
University Hospital, RouenNot yet recruitingChild Development | Child Mental Disorder | Adolescent Behavior | Child Behavior Disorders | Behavior, Child | Adolescent Development | Adolescent - Emotional Problem | Child Development Disorder
-
Boston Medical CenterCenter for the Study of Social PolicyCompletedChild Abuse | Parenting | Child Development | Child Rearing | Child NeglectUnited States
-
University of LiegeActive, not recruitingParent-Child Relations | Child DevelopmentBelgium
Clinical Trials on Infantil formula
-
HiPP GmbH & Co. Vertrieb KGCharite University, Berlin, GermanyCompletedDisturbance of GrowthGermany, Austria, Serbia
-
HiPP GmbH & Co. Vertrieb KGTerminatedInfantile ColicGermany, Italy
-
HiPP GmbH & Co. Vertrieb KGBiofortis Mérieux NutriSciencesTerminated
-
HiPP GmbH & Co. Vertrieb KGActive, not recruitingAtopic DiseasesFrance, Germany, Spain, Czechia, Bulgaria, Finland, Italy, Poland, Portugal, Serbia
-
Dr. Sami Ulus Children's HospitalUnknownGrowth Failure | Neurodevelopmental DisorderTurkey
-
Danone NutriciaNot yet recruiting
-
Société des Produits Nestlé (SPN)CompletedFeeding DisorderPhilippines, Hong Kong, Taiwan, Thailand
-
Abbott NutritionCompleted
-
Société des Produits Nestlé (SPN)Completed
-
Boehringer IngelheimCompleted