<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/NCT02971904</url>
  </required_header>
  <id_info>
    <org_study_id>DanoneELN-02</org_study_id>
    <nct_id>NCT02971904</nct_id>
  </id_info>
  <brief_title>Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants</brief_title>
  <acronym>MISTU</acronym>
  <official_title>Analyzer of Human Milk: Applicability in Clinical Practice in Order to Achieve the Best Nutrition for Infants: Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danone Early Life Nutrition Brazil</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Irmandade da Santa Casa de Misericordia de Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Danone Early Life Nutrition Brazil</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An observational and prospective study involving about 30 healthy lactating mothers whose&#xD;
      preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and&#xD;
      who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until&#xD;
      15th day of hospitalization or until discharge.&#xD;
&#xD;
      Considering the lack of evidence related to breast milk nutritional composition from&#xD;
      Brazilian lactating mothers of preterm infants; and also the utilization of human milk&#xD;
      analyzer as a tool to optimize nutritional therapy and reach proper growth and development of&#xD;
      preterm babies, this study aim to evaluate the nutritional composition of human milk from&#xD;
      lactating mothers of preterm infant during the hospitalization, the infant grow and also the&#xD;
      applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational and prospective study involving approximately 30 healthy lactating&#xD;
      mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit from the&#xD;
      Hospital Santa Casa de Misericordia after childbirth. Lactating mothers should have enough&#xD;
      milk to provide enough maternal milk their infant(s) require plus additional collection of&#xD;
      samples (3mL). After consenting to the study, milk from lactating mothers of preterm infants&#xD;
      in the local ICU will be analyzed daily from the moment they express sufficient milk volume&#xD;
      beyond their child's requirement until discharge (from 4th day of admission until 15th day of&#xD;
      hospitalization ). Three mL of sample milk will be collected every morning and analyzed,&#xD;
      according to hospital routine. Characteristics of subjects and details of their premature&#xD;
      children, such as gestational age, birth weight (BMI) and birth details (causes of preterm&#xD;
      birth, delivery, complications, etc) will be collected by applying a questionnaire on the&#xD;
      first day of analysis. The nutritional composition of the last meal before the milk sample&#xD;
      collection and also a three no consecutive nutrition questionnaire daily intake will be&#xD;
      evaluated.&#xD;
&#xD;
      The determination of the macronutrient content will be made from the use of Human Milk&#xD;
      Analyzer MIRIS (MIRIS HMA), Uppsala, Switzerland, properly calibrated. The analyzer is based&#xD;
      on the adopted infrared (IR) technology in combination with a patented technology. Sample&#xD;
      collection, storage and analysis, as well as equipment conservation, will be carefully&#xD;
      followed according to MIRIS protocol. Information about effectiveness, feasibility and&#xD;
      equipment costs will also be evaluated. The data obtained by the HMA will be compared to the&#xD;
      nutritional composition of human milk and nutritional needs of preterm found in the&#xD;
      literature and included in the main guidelines&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Days</target_duration>
  <primary_outcome>
    <measure>evolution of the nutritional composition of maternal milk of mothers of premature infants</measure>
    <time_frame>up to six months</time_frame>
    <description>Maternal milk energy and protein daily analysis by MIRIS (Mid infrared Human Milk Analyzer)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of mother´s diet in the milk composition</measure>
    <time_frame>up to six months</time_frame>
    <description>Maternal diet questionnaire in admission and daily last meal record before every human milk collection</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Low-Birth-Weight Infant</condition>
  <condition>Premature Infants</condition>
  <arm_group>
    <arm_group_label>Human milk collection</arm_group_label>
    <description>Lactating mothers should have enough milk to provide enough maternal milk their preterm infant(s) require plus additional collection of samples (3mL). After consenting to the study, milk from lactating mothers of preterm infants in the local ICU will be analyzed daily from the moment they express sufficient milk volume beyond their child's requirement until discharge (from 4th day of admission until 15th day of hospitalization ). Three mL of sample milk will be collected every morning and analyzed, according to hospital routine. Personal details of mothers and their infants will be collected by applying a questionnaire on the first day of analysis. The nutritional composition of the last meal before the milk sample collection and also a nutrition questionnaire intake will be evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>human milk collection</intervention_name>
    <arm_group_label>Human milk collection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy, stable mothers, mothers of premature infants who were hospitalized at the neonatal&#xD;
        ICU of the Santa Casa de Misericórdia after the birth. Mothers should have enough milk to&#xD;
        breastfeed their children, and samples will be collected from April to July 2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy mothers with hospitalized preterm newborns&#xD;
&#xD;
          -  Enough milk to breastfeed their child and donate 3 ml / day for the study&#xD;
&#xD;
          -  Being the first sample of milk collected from the 4th day of hospitalization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mothers who are not breastfeeding&#xD;
&#xD;
          -  Do not have enough milk for collection.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>newborn</keyword>
  <keyword>prematurity</keyword>
  <keyword>preterm</keyword>
  <keyword>human milk</keyword>
  <keyword>human milk analyzer</keyword>
  <keyword>neonatology</keyword>
  <keyword>neonatal intensive care unit</keyword>
  <keyword>low birth weight</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Birth Weight</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02971904
org study id: DanoneELN-02
nct id: NCT02971904
lead sponsor: 
collaborator: 
has dmc: Yes
An observational and prospective study involving about 30 healthy lactating mothers whose
      preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit after childbirth and
      who can provide enough maternal milk (3mL) to be analyzed from 4th day of admission until
      15th day of hospitalization or until discharge.

      Considering the lack of evidence related to breast milk nutritional composition from
      Brazilian lactating mothers of preterm infants; and also the utilization of human milk
      analyzer as a tool to optimize nutritional therapy and reach proper growth and development of
      preterm babies, this study aim to evaluate the nutritional composition of human milk from
      lactating mothers of preterm infant during the hospitalization, the infant grow and also the
      applicability of mid infrared (MIR) human milk analyzer (HMA) as a methodology.
This is an observational and prospective study involving approximately 30 healthy lactating
      mothers whose preterm infant(s) is/are hospitalized at Neonatal Intensive Care Unit from the
      Hospital Santa Casa de Misericordia after childbirth. Lactating mothers should have enough
      milk to provide enough maternal milk their infant(s) require plus additional collection of
      samples (3mL). After consenting to the study, milk from lactating mothers of preterm infants
      in the local ICU will be analyzed daily from the moment they express sufficient milk volume
      beyond their child's requirement until discharge (from 4th day of admission until 15th day of
      hospitalization ). Three mL of sample milk will be collected every morning and analyzed,
      according to hospital routine. Characteristics of subjects and details of their premature
      children, such as gestational age, birth weight (BMI) and birth details (causes of preterm
      birth, delivery, complications, etc) will be collected by applying a questionnaire on the
      first day of analysis. The nutritional composition of the last meal before the milk sample
      collection and also a three no consecutive nutrition questionnaire daily intake will be
      evaluated.

      The determination of the macronutrient content will be made from the use of Human Milk
      Analyzer MIRIS (MIRIS HMA), Uppsala, Switzerland, properly calibrated. The analyzer is based
      on the adopted infrared (IR) technology in combination with a patented technology. Sample
      collection, storage and analysis, as well as equipment conservation, will be carefully
      followed according to MIRIS protocol. Information about effectiveness, feasibility and
      equipment costs will also be evaluated. The data obtained by the HMA will be compared to the
      nutritional composition of human milk and nutritional needs of preterm found in the
      literature and included in the main guidelines
observational model: Case-Only
time perspective: Prospective
measure: evolution of the nutritional composition of maternal milk of mothers of premature infants
time frame: up to six months
description: Maternal milk energy and protein daily analysis by MIRIS (Mid infrared Human Milk Analyzer)
measure: Impact of mother´s diet in the milk composition
time frame: up to six months
description: Maternal diet questionnaire in admission and daily last meal record before every human milk collection
arm group label: Human milk collection
description: Lactating mothers should have enough milk to provide enough maternal milk their preterm infant(s) require plus additional collection of samples (3mL). After consenting to the study, milk from lactating mothers of preterm infants in the local ICU will be analyzed daily from the moment they express sufficient milk volume beyond their child's requirement until discharge (from 4th day of admission until 15th day of hospitalization ). Three mL of sample milk will be collected every morning and analyzed, according to hospital routine. Personal details of mothers and their infants will be collected by applying a questionnaire on the first day of analysis. The nutritional composition of the last meal before the milk sample collection and also a nutrition questionnaire intake will be evaluated.
intervention type: Other
intervention name: human milk collection
arm group label: Human milk collection
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Birth Weight
sharing ipd: Undecided