<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02997826</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01403-48</org_study_id>
    <nct_id>NCT02997826</nct_id>
  </id_info>
  <brief_title>Effect of Infant Formula Intake on Infant Growth From 0 to 6 Months.</brief_title>
  <acronym>BABYMILK</acronym>
  <official_title>Effect of Infant Formula Consumption on Infant Growth From 0 to 6 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Pasteur de Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Pasteur de Lille</source>
  <brief_summary>
    <textblock>
      From birth to 5 months, milk is the essential and unique food of the newborn. The French&#xD;
      National Nutrition Program (PNNS) recommends exclusive breastfeeding &quot;up to 6 months and at&#xD;
      least 4 months for a healthy benefit&quot;. However, only 36% of infants 0-6 months of age are&#xD;
      exclusively breastfed worldwide. Some mothers choose to give infant formula to their baby in&#xD;
      the first few months of life. This decision may be a personal choice or be imposed by&#xD;
      pathophysiological situations.&#xD;
&#xD;
      The nutritional requirements of the infant are specific, which implies adequate nutrition.&#xD;
      Infant formulas and follow-up formulas are therefore complex products, specially developed&#xD;
      for a group of vulnerable consumers. In fact, the compositional and information requirements&#xD;
      for infant formula are highly regulated.&#xD;
&#xD;
      Even clinical studies are not required to market an infant formula, it is important to obtain&#xD;
      objective date on infant growth. Therefore, this study proposes to evaluate the effect of the&#xD;
      consumption of an infant formula on the growth of infants from 0 to 6 months in comparison&#xD;
      with the growth curves of the World Health Organization (WHO).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 14, 2016</start_date>
  <completion_date type="Actual">October 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight evolution of infants fed with infant formula</measure>
    <time_frame>from 0 to 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight evolution of infants fed with infant formula</measure>
    <time_frame>from 0 to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height evolution of infants fed with infant formula</measure>
    <time_frame>from 0 to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference evolution of infants fed with infant formula</measure>
    <time_frame>from 0 to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Child Development</condition>
  <arm_group>
    <arm_group_label>1 to 21-days old child</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infantil formula</intervention_name>
    <arm_group_label>1 to 21-days old child</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  0 to 3 weeks&#xD;
&#xD;
          -  Infants whose mothers do not wish or can not breastfeed for personal or medical&#xD;
             reasons&#xD;
&#xD;
          -  Child followed by a general practitioner or pediatrician&#xD;
&#xD;
          -  Informed consent form signed by the legal representatives of the subject&#xD;
&#xD;
          -  Commitment of legal representatives to follow the constraints generated by the study&#xD;
&#xD;
          -  Insured&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nursing mother&#xD;
&#xD;
          -  Infant born prematurely before 37 weeks of amenorrhea&#xD;
&#xD;
          -  Child allergic to cow's milk proteins&#xD;
&#xD;
          -  Pathological pregnancy (hypertension, infection, gestational diabetes, etc.);&#xD;
&#xD;
          -  Chronic or acute illness (metabolic or neuromuscular diseases, epilepsy, asthma,&#xD;
             diabetes, digestive, renal, cardiac or haematological diseases);&#xD;
&#xD;
          -  Incapacity for the legal representative(s) to understand or adhere to the protocol&#xD;
&#xD;
          -  Mother smoking or vapoting during pregnancy;&#xD;
&#xD;
          -  Subject involved in another clinical study or in an exclusion period from another&#xD;
             study&#xD;
&#xD;
          -  Legal representatives deprived of liberty&#xD;
&#xD;
          -  Legal representatives in a position to judicial protection&#xD;
&#xD;
          -  Weight of the subject according to age and sex, not included between the 3rd and the&#xD;
             97th percentile of the WHO Child Growth Standards&#xD;
&#xD;
          -  Subject height according to age and sex, not between the 3rd and the 97th percentile&#xD;
             of the WHO Child Growth Standards&#xD;
&#xD;
          -  BMI of the subject according to age and sex, not included between the 3rd and the 97th&#xD;
             percentile of the WHO Child Growth Standards&#xD;
&#xD;
          -  Head circumference of the subject according to age and sex, not included between the&#xD;
             3rd and the 97th percentile of the WHO Child Growth Standards&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>21 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Michel Lecerf, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Pasteur de Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Pasteur de Lille</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 6, 2022</last_update_submitted>
  <last_update_submitted_qc>December 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut Pasteur de Lille</investigator_affiliation>
    <investigator_full_name>Jean-Michel Lecerf</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02997826
org study id: 2016-A01403-48
nct id: NCT02997826
lead sponsor: 
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).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Weight evolution of infants fed with infant formula
time frame: from 0 to 3 months
measure: Weight evolution of infants fed with infant formula
time frame: from 0 to 6 months
measure: Height evolution of infants fed with infant formula
time frame: from 0 to 6 months
measure: Head circumference evolution of infants fed with infant formula
time frame: from 0 to 6 months
arm group label: 1 to 21-days old child
arm group type: Other
intervention type: Other
intervention name: Infantil formula
arm group label: 1 to 21-days old child
criteria: 
gender: All
minimum age: 1 Day
maximum age: 21 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Jean-Michel Lecerf, MD
role: Principal Investigator
affiliation: Institut Pasteur de Lille
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Institut Pasteur de Lille
investigator full name: Jean-Michel Lecerf
investigator title: Professor