<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/NCT02184650</url>
  </required_header>
  <id_info>
    <org_study_id>NI 13016</org_study_id>
    <secondary_id>ID RCB 2014-A00941-46</secondary_id>
    <nct_id>NCT02184650</nct_id>
  </id_info>
  <brief_title>Nutrition and Neurological Development of Very Preterm Infants</brief_title>
  <acronym>EPINUTRI_3</acronym>
  <official_title>Early Nutrition and Neurological Development of Very Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main goal of this study is to determine, in preterm infants born with a GA &lt; 32 weeks,&#xD;
      the association between:&#xD;
&#xD;
        -  the quantity of mother's milk and duration and breastfeeding&#xD;
&#xD;
        -  the intake of polyunsaturated fatty acids and iron during hospitalizations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main hypothesis of this study is that the intake of lipid during hospitalization in&#xD;
      neonatology department is associated with neurological development of preterm infants born&#xD;
      with a GA &lt; 32 weeks. The other hypotheses are that iron intake and the duration of&#xD;
      breastfeeding are also associated with the development of preterm infants.&#xD;
&#xD;
      In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until&#xD;
      the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.&#xD;
&#xD;
      The aim of EPINUTRI_3 study is to determine the association between lipid intake during&#xD;
      hospitalization in neonatology department of preterm infants born with a GA &lt; 32 weeks.&#xD;
&#xD;
      The secondary objective is :&#xD;
&#xD;
      - to evaluate the association between these factors and communication, developmental and&#xD;
      social-emotional delays with the test &quot; Ages and Stages questionnaire &quot; (ASQ) at 3 years of&#xD;
      age.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Neurological development</measure>
    <time_frame>At 3 years of age</time_frame>
    <description>Age and Stages Questionnaire</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">206</enrollment>
  <condition>Premature Infant</condition>
  <condition>Infant Nutrition Disorders</condition>
  <condition>Delayed Mental Development</condition>
  <arm_group>
    <arm_group_label>Premature infants</arm_group_label>
    <description>Premature infants with a GA &lt; 32 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Premature infants with a GA &lt; 32 weeks</intervention_name>
    <description>At 3 years of age: ASQ (filled in by parents)</description>
    <arm_group_label>Premature infants</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      saliva, whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subsample of infants born very preterm (before 32 weeks of gestation), otherwise included&#xD;
        in the French national cohort EPIPAGE 2, and previously included in EPINUTRI study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premature infants previously included in EPINUTRI study&#xD;
&#xD;
          -  Non opposition of the parents for the collection of clinical and nutritional data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of the parents to collect clinical and nutritional data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre Lapillonne, M.D, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Necker Assistance Publique-Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Necker Assistance Publique- Hôpitaux de Paris</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Premature infants</keyword>
  <keyword>Nutritional status</keyword>
  <keyword>Polyunsaturated fatty acids status</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Infant Nutrition Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02184650
org study id: NI 13016
secondary id: ID RCB 2014-A00941-46
nct id: NCT02184650
lead sponsor: 
has dmc: No
The main goal of this study is to determine, in preterm infants born with a GA < 32 weeks,
      the association between:

        -  the quantity of mother's milk and duration and breastfeeding

        -  the intake of polyunsaturated fatty acids and iron during hospitalizations
The main hypothesis of this study is that the intake of lipid during hospitalization in
      neonatology department is associated with neurological development of preterm infants born
      with a GA < 32 weeks. The other hypotheses are that iron intake and the duration of
      breastfeeding are also associated with the development of preterm infants.

      In the previous study EPINUTRI (NCT01486173), the development of infants was evaluated until
      the age of 1 year. EPINUTRI_3 is the follow-up of EPINUTRI until the age of 3 years.

      The aim of EPINUTRI_3 study is to determine the association between lipid intake during
      hospitalization in neonatology department of preterm infants born with a GA < 32 weeks.

      The secondary objective is :

      - to evaluate the association between these factors and communication, developmental and
      social-emotional delays with the test " Ages and Stages questionnaire " (ASQ) at 3 years of
      age.
observational model: Cohort
time perspective: Prospective
measure: Neurological development
time frame: At 3 years of age
description: Age and Stages Questionnaire
arm group label: Premature infants
description: Premature infants with a GA < 32 weeks
intervention type: Other
intervention name: Premature infants with a GA < 32 weeks
description: At 3 years of age: ASQ (filled in by parents)
arm group label: Premature infants
saliva, whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 3 Years
healthy volunteers: No
last name: Alexandre Lapillonne, M.D, Ph.D.
role: Principal Investigator
affiliation: Hôpital Necker Assistance Publique-Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Nutrition Disorders
mesh term: Infant Nutrition Disorders