<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/NCT04442477</url>
  </required_header>
  <id_info>
    <org_study_id>6027-2</org_study_id>
    <nct_id>NCT04442477</nct_id>
  </id_info>
  <brief_title>Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions</brief_title>
  <official_title>Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mead Johnson Nutrition</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mead Johnson Nutrition</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>
      This is a follow-up study of a multi-center, double-blind, randomized, controlled,&#xD;
      parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5&#xD;
      years of age and health outcomes through 5.5 years of age in participants who received one of&#xD;
      two staged study formulas through one year of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">May 27, 2021</completion_date>
  <primary_completion_date type="Actual">May 27, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Wechsler Preschool &amp; Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)</measure>
    <time_frame>At 5.5 years of age</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dimensional Change Card Sort (DCCS)</measure>
    <time_frame>At 5.5 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroop Task</measure>
    <time_frame>At 5.5 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Near Infrared Spectroscopy (fNIRS)</measure>
    <time_frame>At 5.5 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Behavior Checklist (CBCL)</measure>
    <time_frame>At 5.5 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>At 5.5 years of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body height</measure>
    <time_frame>At 5.5 year of age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health history outcomes</measure>
    <time_frame>At 5.5 years of age</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">116</enrollment>
  <condition>Cognitive Ability, General</condition>
  <arm_group>
    <arm_group_label>Experimental: Enriched Protein Fractions</arm_group_label>
    <description>This group was given Infant formula with enriched protein fractions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: Protein Fractions</arm_group_label>
    <description>This group was given Infant formula with protein fractions</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Enriched Protein Fractions</intervention_name>
    <description>Enriched protein fractions</description>
    <arm_group_label>Experimental: Enriched Protein Fractions</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein Fraction</intervention_name>
    <description>Protein fractions</description>
    <arm_group_label>Active Comparator: Protein Fractions</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who previously consumed study formula through one year of age in MJN Project&#xD;
        6027.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant who previously consumed study formula through one year of age in MJN&#xD;
             Project 6027&#xD;
&#xD;
          -  5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit&#xD;
             1&#xD;
&#xD;
          -  Signed informed consent obtained for child's participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No exclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>64 Months</minimum_age>
    <maximum_age>68 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fei Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Children's Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Steven Wu, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Mead Johnson/RB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fuyang Fifth People's Hospital</name>
      <address>
        <city>Anhui</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>December 15, 2021</last_update_submitted>
  <last_update_submitted_qc>December 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04442477
org study id: 6027-2
nct id: NCT04442477
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a follow-up study of a multi-center, double-blind, randomized, controlled,
      parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5
      years of age and health outcomes through 5.5 years of age in participants who received one of
      two staged study formulas through one year of age.
observational model: Cohort
time perspective: Prospective
measure: Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
time frame: At 5.5 years of age
measure: Dimensional Change Card Sort (DCCS)
time frame: At 5.5 years of age
measure: Stroop Task
time frame: At 5.5 years of age
measure: Functional Near Infrared Spectroscopy (fNIRS)
time frame: At 5.5 years of age
measure: Child Behavior Checklist (CBCL)
time frame: At 5.5 years of age
measure: Body weight
time frame: At 5.5 years of age
measure: Body height
time frame: At 5.5 year of age
measure: Health history outcomes
time frame: At 5.5 years of age
arm group label: Experimental: Enriched Protein Fractions
description: This group was given Infant formula with enriched protein fractions
arm group label: Active Comparator: Protein Fractions
description: This group was given Infant formula with protein fractions
intervention type: Dietary Supplement
intervention name: Enriched Protein Fractions
description: Enriched protein fractions
arm group label: Experimental: Enriched Protein Fractions
intervention type: Dietary Supplement
intervention name: Protein Fraction
description: Protein fractions
arm group label: Active Comparator: Protein Fractions
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 64 Months
maximum age: 68 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Fei Li
role: Principal Investigator
affiliation: Shanghai Children's Medical Center
last name: Steven Wu, M.D.
role: Study Director
affiliation: Mead Johnson/RB
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No