<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/NCT02231801</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 14-1323</org_study_id>
    <secondary_id>PD14-03941</secondary_id>
    <nct_id>NCT02231801</nct_id>
  </id_info>
  <brief_title>Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies</brief_title>
  <official_title>Vital Sign Monitoring of Mother-Infant Dyads During Kangaroo Care in Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study aims to monitor the vital sign changes in both mother and baby that&#xD;
      occur during kangaroo care in preterm infants and to investigate any potential correlations&#xD;
      between maternal measurement values and those of the infant. The purpose of this&#xD;
      observational study is to look for a method to track the earliest responses that could,&#xD;
      theoretically, be considered as 'social responses' in hopes of providing developmental&#xD;
      interventions earlier to at-risk infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this observational study is to identify any signs of early &quot;social response&quot; in&#xD;
      order to be able to assist infants that lack this response with early neurobehavioral&#xD;
      modifications.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 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>Heart Rate</measure>
    <time_frame>up to 30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate</measure>
    <time_frame>up to 30 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen Saturation</measure>
    <time_frame>up to 30 minutes</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Other Preterm Infants</condition>
  <arm_group>
    <arm_group_label>Mother-Infant Dyad</arm_group_label>
    <description>Skin-to-skin holding of preterm infants by their mothers</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mother-Infant Dyad</intervention_name>
    <description>Skin-to-skin holding of preterm infants by their mothers</description>
    <arm_group_label>Mother-Infant Dyad</arm_group_label>
    <other_name>Kangaroo Care</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infants born at Mt. Sinai Hospital and admitted to the NICU. Preterm infants between 30 0/7&#xD;
        weeks gestational age to 34 6/7 weeks gestation age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  inborn at Mount Sinai&#xD;
&#xD;
          -  gestational age between 30 0/7 weeks and 34 6/7 weeks gestation&#xD;
&#xD;
          -  only one infant of a multiple gestation&#xD;
&#xD;
          -  plan by family to do kangaroo care during NICU stay&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  outborn infants&#xD;
&#xD;
          -  gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks&#xD;
&#xD;
          -  other infants of multiple gestation (see inclusion criteria)&#xD;
&#xD;
          -  any major congenital anomalies&#xD;
&#xD;
          -  sepsis and/or any other serious clinical complication precluding kangaroo care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Weeks</minimum_age>
    <maximum_age>35 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian Holzman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>December 29, 2015</last_update_submitted>
  <last_update_submitted_qc>December 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Preterm</keyword>
  <keyword>Kangaroo Care</keyword>
  <keyword>Skin-to-Skin</keyword>
  <keyword>Vital Sign</keyword>
  <keyword>Heart Rate</keyword>
  <keyword>Respiratory Rate</keyword>
  <keyword>Oxygen Saturation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT02231801
org study id: GCO 14-1323
secondary id: PD14-03941
nct id: NCT02231801
lead sponsor: 
has dmc: No
This observational study aims to monitor the vital sign changes in both mother and baby that
      occur during kangaroo care in preterm infants and to investigate any potential correlations
      between maternal measurement values and those of the infant. The purpose of this
      observational study is to look for a method to track the earliest responses that could,
      theoretically, be considered as 'social responses' in hopes of providing developmental
      interventions earlier to at-risk infants.
The goal of this observational study is to identify any signs of early "social response" in
      order to be able to assist infants that lack this response with early neurobehavioral
      modifications.
observational model: Cohort
time perspective: Prospective
measure: Heart Rate
time frame: up to 30 minutes
measure: Respiratory Rate
time frame: up to 30 minutes
measure: Oxygen Saturation
time frame: up to 30 minutes
arm group label: Mother-Infant Dyad
description: Skin-to-skin holding of preterm infants by their mothers
intervention type: Behavioral
intervention name: Mother-Infant Dyad
description: Skin-to-skin holding of preterm infants by their mothers
arm group label: Mother-Infant Dyad
other name: Kangaroo Care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Weeks
maximum age: 35 Weeks
healthy volunteers: No
last name: Ian Holzman, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
country: United States
responsible party type: Sponsor
mesh term: Premature Birth