<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/NCT03252327</url>
  </required_header>
  <id_info>
    <org_study_id>2-106-05-080</org_study_id>
    <nct_id>NCT03252327</nct_id>
  </id_info>
  <brief_title>Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes</brief_title>
  <official_title>Effects of the Interventions Using Multiple Sensory Integrations on Relieving Pain and Distress in Preterm Infants During Peripheral Venous Puncture Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Defense Medical Center, Taiwan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Defense Medical Center, Taiwan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Frequent pain and distress may affect infants' brain and neural development, and highlight&#xD;
      the need for relieve pain interventions. Peripheral venous puncture procedures are an&#xD;
      important source of preterm infants' pain and distress. Brain development is mainly created&#xD;
      by infant sensory experience. It becomes important, therefore, to relieve preterm infants'&#xD;
      pain and distress using multiple sensory integrations during peripheral venous puncture&#xD;
      procedures.The proposed 2-year study has specific aim: to compare the effects of different&#xD;
      combination of sensory integrations on preterm infants' pain and distress before, during, and&#xD;
      after peripheral venous puncture procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 26, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Preterm infants' pain</measure>
    <time_frame>20-30 minutes (during peripheral venous puncture procedures)</time_frame>
    <description>Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score &lt;7 suggests no or little pain, 7-12 mild to moderate pain and scores &gt;12 indicate moderate to severe pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>preterm infants' physiological parameters:heart rate</measure>
    <time_frame>20-30 minutes (during peripheral venous puncture procedures)</time_frame>
    <description>Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm infants' physiological parameters:respiration rate</measure>
    <time_frame>20-30 minutes (during peripheral venous puncture procedures)</time_frame>
    <description>Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm infants' physiological parameters: oxygen saturation</measure>
    <time_frame>20-30 minutes (during peripheral venous puncture procedures)</time_frame>
    <description>Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>preterm infants' behavioral responses</measure>
    <time_frame>20-30 minutes (during peripheral venous puncture procedures)</time_frame>
    <description>The infant behavioral responses will be measured by using an infant behavioral coding scheme. Behavioral data during venous puncture procedures will be collected using a real-time colour video recorder. Frequency ratios for pain and distress behaviors, include: facial activity (e.g. brow bulge, eye squeeze, nasolabial furrow), body movement, cry, transition between sleep and wake states.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>preterm infants' duration of fussing and cry</measure>
    <time_frame>20-30 minutes (during peripheral venous puncture procedures)</time_frame>
    <description>Fussing and crying will be record from the recording pen in minutes.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Preterm Infants</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>routine care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sensory Integrations(1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sensory Integrations(2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Sensory Integrations(3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multiple Sensory Integrations</intervention_name>
    <description>breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.</description>
    <arm_group_label>Multiple Sensory Integrations(1)</arm_group_label>
    <arm_group_label>Multiple Sensory Integrations(2)</arm_group_label>
    <arm_group_label>Multiple Sensory Integrations(3)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age (GA) 28-37 weeks&#xD;
&#xD;
          -  Post-menstrual age (PMA) 29-38 weeks&#xD;
&#xD;
          -  Postnatal age 3-28 days&#xD;
&#xD;
          -  Sable condition (NTISSscore ≦ 22)&#xD;
&#xD;
          -  Apgar scores≧7 at 5 minutes after birth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurologic impairment&#xD;
&#xD;
          -  Congenital anomalies&#xD;
&#xD;
          -  Surgery&#xD;
&#xD;
          -  Severe growth restriction at birth&#xD;
&#xD;
          -  Severe medical conditions requiring treatments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Days</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>May 9, 2019</last_update_submitted>
  <last_update_submitted_qc>May 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Defense Medical Center, Taiwan</investigator_affiliation>
    <investigator_full_name>Hsiang-Ping Wu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT03252327
org study id: 2-106-05-080
nct id: NCT03252327
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Frequent pain and distress may affect infants' brain and neural development, and highlight
      the need for relieve pain interventions. Peripheral venous puncture procedures are an
      important source of preterm infants' pain and distress. Brain development is mainly created
      by infant sensory experience. It becomes important, therefore, to relieve preterm infants'
      pain and distress using multiple sensory integrations during peripheral venous puncture
      procedures.The proposed 2-year study has specific aim: to compare the effects of different
      combination of sensory integrations on preterm infants' pain and distress before, during, and
      after peripheral venous puncture procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Preterm infants' pain
time frame: 20-30 minutes (during peripheral venous puncture procedures)
description: Premature Infant Pain Profile-Revised (PIPP-R) for pain, A score <7 suggests no or little pain, 7-12 mild to moderate pain and scores >12 indicate moderate to severe pain.
measure: preterm infants' physiological parameters:heart rate
time frame: 20-30 minutes (during peripheral venous puncture procedures)
description: Heart rate will be recorded from ECG leads. Heart rate in beats per minute (mean of physiological parameters)
measure: Preterm infants' physiological parameters:respiration rate
time frame: 20-30 minutes (during peripheral venous puncture procedures)
description: Respiration rate will be recorded from ECG leads. Respiration rate in breaths per minute. (mean of physiological parameters)
measure: Preterm infants' physiological parameters: oxygen saturation
time frame: 20-30 minutes (during peripheral venous puncture procedures)
description: Oxygen saturation will be recorded from ECG leads. Oxygen saturation in % (mean of physiological parameters)
measure: preterm infants' behavioral responses
time frame: 20-30 minutes (during peripheral venous puncture procedures)
description: The infant behavioral responses will be measured by using an infant behavioral coding scheme. Behavioral data during venous puncture procedures will be collected using a real-time colour video recorder. Frequency ratios for pain and distress behaviors, include: facial activity (e.g. brow bulge, eye squeeze, nasolabial furrow), body movement, cry, transition between sleep and wake states.
measure: preterm infants' duration of fussing and cry
time frame: 20-30 minutes (during peripheral venous puncture procedures)
description: Fussing and crying will be record from the recording pen in minutes.
arm group label: routine care
arm group type: No Intervention
description: Preterm infants in the control condition will receive only usual neonatal intensive care units (NICU) care
arm group label: Multiple Sensory Integrations(1)
arm group type: Experimental
description: The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
arm group label: Multiple Sensory Integrations(2)
arm group type: Experimental
description: The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
arm group label: Multiple Sensory Integrations(3)
arm group type: Experimental
description: The sensory integrations are provided through combining the use of sensory integrations ( olfactory, taste, auditory or tactile).
intervention type: Other
intervention name: Multiple Sensory Integrations
description: breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.
arm group label: Multiple Sensory Integrations(1)
arm group label: Multiple Sensory Integrations(2)
arm group label: Multiple Sensory Integrations(3)
criteria: 
gender: All
minimum age: 3 Days
maximum age: 28 Days
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Defense Medical Center, Taiwan
investigator full name: Hsiang-Ping Wu
investigator title: Principal Investigator
mesh term: Premature Birth