<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/NCT03004677</url>
  </required_header>
  <id_info>
    <org_study_id>Linkoeping University</org_study_id>
    <nct_id>NCT03004677</nct_id>
  </id_info>
  <brief_title>Effect of Skin-to-skin Contact on Interaction and Parents' Sleep</brief_title>
  <acronym>Neo-SIPaS</acronym>
  <official_title>Effect of Skin-to-skin Contact on Interaction and Parents' Sleep</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the effect of a late intervention of continuous skin-to-skin contact&#xD;
      (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the&#xD;
      intervention and the other half will receive standard care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention is based on a method developed to facilitate closeness and human touch&#xD;
      between parents and preterm infants in neonatal intensive care. Continuous skin-to-skin&#xD;
      contact (SSC) means, in this study, that the late preterm infant is cared for skin-to-skin on&#xD;
      the parents' chest, instead of in a heating-bed, 24 hours a day. The parents will take turns&#xD;
      to care for the infant in SSC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    To difficult to recruit.&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Day 1 to 5</time_frame>
    <description>sleep diary every day for five days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>day 2 to 5</time_frame>
    <description>Mood Adjective Checklist (MACL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bonding</measure>
    <time_frame>Baseline and 1-3 days before planned discharge from the NICU.</time_frame>
    <description>Mother to Infant Bonding Scale (MIBS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Baseline and 1-3 days before planned discharge from the NICU.</time_frame>
    <description>The Edinburgh Postnatal Depression Scale, EPDS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Baseline and 1-3 days before planned discharge from the NICU.</time_frame>
    <description>State Trait Anxiety Inventory, STAI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity</measure>
    <time_frame>Day 1-5</time_frame>
    <description>Actigraph every day for five days</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Sleep Quality</condition>
  <condition>Communication</condition>
  <condition>Stress Reaction</condition>
  <arm_group>
    <arm_group_label>Continuous skin-to-skin contact</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infants and parents will receive standard care provided in the NICU</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Continuous skin-to-skin contact</intervention_name>
    <description>Infants will rest in skin-to-skin contact on parents' chest 24 hours a day alternating between the parents. The parents will note who provides the SSC and if and for how long they are off SSC for any reason.</description>
    <arm_group_label>Continuous skin-to-skin contact</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Infants will receive regular care in the NICU. Parents may practice SSC if they like. Parents will note if, with whom, and for how long they provide SSC.</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents staying at the NICU with a single preterm infant born &lt;33 weeks of gestation&#xD;
&#xD;
          -  The family should have been transferred to family-room from intensive care&#xD;
&#xD;
          -  Swedish speaking parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants with major congenital malformation,&#xD;
&#xD;
          -  Infants with intraventricular hemorrhage grade III-IV&#xD;
&#xD;
          -  Infants with chromosome defect that could affect the infant´s ability to interact.&#xD;
&#xD;
          -  Parents with sleeping disorder&#xD;
&#xD;
          -  Parents with psychiatric problem or drug use.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evalotte Mörelius, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Linkoping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University hospital Örebro</name>
      <address>
        <city>Örebro</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>March 1, 2020</last_update_submitted>
  <last_update_submitted_qc>March 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Evalotte Morelius</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Stress</mesh_term>
  </condition_browse>
  <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/NCT03004677
org study id: Linkoeping University
nct id: NCT03004677
lead sponsor: 
has dmc: No
This study evaluates the effect of a late intervention of continuous skin-to-skin contact
      (SSC) in the neonatal intensive care unit (NICU). Half of the participants will receive the
      intervention and the other half will receive standard care.
The intervention is based on a method developed to facilitate closeness and human touch
      between parents and preterm infants in neonatal intensive care. Continuous skin-to-skin
      contact (SSC) means, in this study, that the late preterm infant is cared for skin-to-skin on
      the parents' chest, instead of in a heating-bed, 24 hours a day. The parents will take turns
      to care for the infant in SSC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Sleep quality
time frame: Day 1 to 5
description: sleep diary every day for five days
measure: Mood
time frame: day 2 to 5
description: Mood Adjective Checklist (MACL)
measure: Bonding
time frame: Baseline and 1-3 days before planned discharge from the NICU.
description: Mother to Infant Bonding Scale (MIBS)
measure: Depression
time frame: Baseline and 1-3 days before planned discharge from the NICU.
description: The Edinburgh Postnatal Depression Scale, EPDS
measure: Anxiety
time frame: Baseline and 1-3 days before planned discharge from the NICU.
description: State Trait Anxiety Inventory, STAI
measure: Activity
time frame: Day 1-5
description: Actigraph every day for five days
arm group label: Continuous skin-to-skin contact
arm group type: Experimental
description: Infants assigned to SSC will rest skin-to-skin on parents' chest 24 hours a day for four days alternating between the parents.
arm group label: Standard Care
arm group type: Active Comparator
description: Infants and parents will receive standard care provided in the NICU
intervention type: Behavioral
intervention name: Continuous skin-to-skin contact
description: Infants will rest in skin-to-skin contact on parents' chest 24 hours a day alternating between the parents. The parents will note who provides the SSC and if and for how long they are off SSC for any reason.
arm group label: Continuous skin-to-skin contact
intervention type: Other
intervention name: Standard Care
description: Infants will receive regular care in the NICU. Parents may practice SSC if they like. Parents will note if, with whom, and for how long they provide SSC.
arm group label: Standard Care
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Evalotte Mörelius, PhD
role: Principal Investigator
affiliation: Linkoeping University
facility: 
facility: 
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Evalotte Morelius
investigator title: Associate professor
mesh term: Fractures, Stress
sharing ipd: No