<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/NCT03833635</url>
  </required_header>
  <id_info>
    <org_study_id>COME-01-18</org_study_id>
    <nct_id>NCT03833635</nct_id>
  </id_info>
  <brief_title>Effects of OMT on Premature Physiological Parameters</brief_title>
  <official_title>Effects of OMT on Premature Physiological Parameters: a RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Come Collaboration</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vittore Buzzi Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Come Collaboration</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteopathic manipulative treatment has been showed to reduce LOS in premature infants.&#xD;
      Despite the clinical effectiveness, lack of data and information on the physiological&#xD;
      underpinning effects during the treatment has been revealed. The aim of the study is to&#xD;
      explore the immediate physiological effects of osteopathic treatment on premature infants&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 22, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>heart rate</measure>
    <time_frame>immediate</time_frame>
    <description>measure of heart rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation</measure>
    <time_frame>immediate</time_frame>
    <description>measure of oxygen</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Premature Infant</condition>
  <condition>Physiological Stress</condition>
  <arm_group>
    <arm_group_label>OMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>osteopathic manipulative treatment</intervention_name>
    <description>OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect</description>
    <arm_group_label>OMT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham</intervention_name>
    <description>the sham intervention consists in a stable skin-to-skin contact with the participant</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  preterm infants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congenital/genetic disease&#xD;
&#xD;
          -  cardiovascular/neurological disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Chieti-Pescara</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Cerritelli, DO, MS</last_name>
      <phone>+393394332801</phone>
      <email>francesco.cerritelli@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Buzzi hospital</name>
      <address>
        <city>Milan</city>
        <zip>20154</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Manzotti, PT, DO</last_name>
      <phone>+3902 2052 0939</phone>
      <email>andreamanzotti@soma-osteopatia.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>March 21, 2019</last_update_submitted>
  <last_update_submitted_qc>March 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03833635
org study id: COME-01-18
nct id: NCT03833635
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Osteopathic manipulative treatment has been showed to reduce LOS in premature infants.
      Despite the clinical effectiveness, lack of data and information on the physiological
      underpinning effects during the treatment has been revealed. The aim of the study is to
      explore the immediate physiological effects of osteopathic treatment on premature infants
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: heart rate
time frame: immediate
description: measure of heart rate
measure: oxygen saturation
time frame: immediate
description: measure of oxygen
arm group label: OMT
arm group type: Experimental
arm group label: Control
arm group type: Placebo Comparator
intervention type: Other
intervention name: osteopathic manipulative treatment
description: OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect
arm group label: OMT
intervention type: Other
intervention name: Sham
description: the sham intervention consists in a stable skin-to-skin contact with the participant
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Months
healthy volunteers: No
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Premature Birth