<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/NCT03276663</url>
  </required_header>
  <id_info>
    <org_study_id>15.01.INF</org_study_id>
    <nct_id>NCT03276663</nct_id>
  </id_info>
  <brief_title>Growth of Healthy Term Infants Fed a Partially Hydrolyzed Follow-up Formula</brief_title>
  <official_title>Effect of a New Formula With a Reduced Concentration of Partially Hydrolyzed Protein on Growth of Healthy Term Infants: an Open-label Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biofortis Mérieux NutriSciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of&#xD;
      an existing partially hydrolyzed starter formula, then subsequently fed a partially&#xD;
      hydrolyzed follow-up formula over the first year of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">June 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 19, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Open-label, two-arm</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months</measure>
    <time_frame>6 month</time_frame>
    <description>compared to the WHO reference standards or to the human milk (HM)-fed comparator group.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">194</enrollment>
  <condition>Growth</condition>
  <arm_group>
    <arm_group_label>Formula fed group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Formula feeding regimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Human milk-fed group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Formula feeding regimen</intervention_name>
    <description>The feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula</description>
    <arm_group_label>Formula fed group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Having obtained his/her parents' (or his/her legally accepted representative's&#xD;
             [LAR's]) written informed consent and having evidence of personally signed and dated&#xD;
             informed consent document indicating that the infant's parents/LAR have been informed&#xD;
             of all pertinent aspects of the study.&#xD;
&#xD;
          2. Age ≤ 14 days after birth (date of birth = Day 0).&#xD;
&#xD;
          3. Full-term gestational birth (≥ 37 and ≤ 42 weeks).&#xD;
&#xD;
          4. Weight at birth ≥ 2500 g and ≤ 4200 g&#xD;
&#xD;
          5. Born to mothers with (normal) pre-pregnancy BMI ≥ 18.5 to &lt; 26 kg/m2.&#xD;
&#xD;
          6. For formula-fed infants: born to mothers who independently elected, before study&#xD;
             enrollment, not to breastfeed, but having received any HM is permitted (not applicable&#xD;
             for infants in the HM-fed group)&#xD;
&#xD;
          7. For HM-fed infants: mothers intend to provide breast milk until age 6 months&#xD;
&#xD;
          8. Infant's parent(s)/LAR is of legal age of consent, has sufficient command of the&#xD;
             French language to complete the informed consent and other study documents, and is&#xD;
             willing and able to fulfill the requirements of the study protocol.&#xD;
&#xD;
          9. Infant's parent(s)/LAR is able to be contacted directly by telephone throughout the&#xD;
             study.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Born to mothers with hormonal or metabolic disease (e.g. Type-1, Type-2, or&#xD;
             gestational diabetes diagnosed according to standardized criteria).&#xD;
&#xD;
          2. Born to mothers who smoked &gt; 10 cigarettes per day during pregnancy.&#xD;
&#xD;
          3. Born to mothers who used illicit drugs (e.g. marijuana, cocaine, amphetamines, or&#xD;
             heroin) or alcohol (&gt; 3 alcoholic beverages per week) during pregnancy.&#xD;
&#xD;
          4. Cognitive or physical developmental disorders (e.g., malabsorptive disorders such as&#xD;
             short bowel syndrome; neurological and congenital disorders that may delay growth such&#xD;
             as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down syndrome, Cri&#xD;
             Du Chat; disorders that may lead to obesity such as Prader Willi syndrome, Angelman&#xD;
             syndrome; other renal, hepatic, pancreatic, or cardiovascular disorders).&#xD;
&#xD;
          5. Participation in any other clinical trial prior to enrollment.&#xD;
&#xD;
          6. Infants or infant's family who in the Investigator's judgment cannot be expected to&#xD;
             comply with the protocol or study procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>14 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claude Billeaud</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Amiens Picardie Site SUD</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hôpital Pellegrin Enfants</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Caen</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes - Hôpital Mère-Enfant</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Necker</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biofortis CIC</name>
      <address>
        <city>Saint-Herblain</city>
        <zip>44800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>July 2, 2020</last_update_submitted>
  <last_update_submitted_qc>July 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03276663
org study id: 15.01.INF
nct id: NCT03276663
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Growth of healthy term formula-fed infants who receive a single feeding regimen consisting of
      an existing partially hydrolyzed starter formula, then subsequently fed a partially
      hydrolyzed follow-up formula over the first year of life.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Open-label, two-arm
primary purpose: Other
masking: None (Open Label)
measure: Growth velocity (weight gain in g/day) of healthy term formula-fed infants during the first 6 months
time frame: 6 month
description: compared to the WHO reference standards or to the human milk (HM)-fed comparator group.
arm group label: Formula fed group
arm group type: Other
description: Formula feeding regimen
arm group label: Human milk-fed group
arm group type: No Intervention
intervention type: Other
intervention name: Formula feeding regimen
description: The feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula
arm group label: Formula fed group
criteria: 
gender: All
minimum age: N/A
maximum age: 14 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Claude Billeaud
role: Principal Investigator
affiliation: CHU Bordeaux
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor