<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/NCT03751787</url>
  </required_header>
  <id_info>
    <org_study_id>2008_43</org_study_id>
    <secondary_id>2009-A00037-50</secondary_id>
    <nct_id>NCT03751787</nct_id>
  </id_info>
  <brief_title>Cranial Osteopathy in Functional Disorders of the Newborn</brief_title>
  <official_title>Interest of Treatment With Cranial Osteopathy in Functional Disorders of the Newborn</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</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>
      To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction&#xD;
      of the hyper irritability of the newborn and the improvement of the postural abnormalities&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of hyper irritability</measure>
    <time_frame>at 28 days of life.</time_frame>
    <description>Reduction of hyper irritability will be done by evaluation from a clinical score,signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2:&#xD;
Excessive and difficult to calm, insufficient sleep&#xD;
postural asymmetry&#xD;
difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling&#xD;
Excessive regurgitation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of hyper irritability</measure>
    <time_frame>before any treatment, at 3 days after deliverance and at 28 days of life</time_frame>
    <description>Reduction of hyper irritability will be done by evaluation from a clinical score, signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2:&#xD;
Excessive and difficult to calm, insufficient sleep&#xD;
postural asymmetry&#xD;
difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling&#xD;
Excessive regurgitation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Newborn Complication</condition>
  <arm_group>
    <arm_group_label>cranial osteopathy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group will receive treatment with osteopathic cranial osteopathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>comfort massage</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cranial osteopathy</intervention_name>
    <description>two sessions at three weeks intervals</description>
    <arm_group_label>cranial osteopathy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>comfort massage</intervention_name>
    <description>manipulation, comfort massage, standardized and not affecting the skull</description>
    <arm_group_label>comfort massage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborns:&#xD;
&#xD;
               -  forward&#xD;
&#xD;
               -  born vaginally or cesarean section&#xD;
&#xD;
               -  with or without general anesthesia&#xD;
&#xD;
               -  with or without epidural or spinal anesthesia&#xD;
&#xD;
               -  with or without instrumental extraction&#xD;
&#xD;
               -  presenting at least 1 of the 4 criteria detailed above, numbered at 3 or 4 or two&#xD;
                  criteria at 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborns presenting:&#xD;
&#xD;
               -  a score of Amiel &lt;7, signing a strong suspicion of non-integrity of brain&#xD;
                  functions (see table) and therefore leaving the framework of functional pathology&#xD;
&#xD;
               -  symptomatic maternal-fetal infection&#xD;
&#xD;
               -  true obstetric trauma: brachial plexus paralysis, fracture&#xD;
&#xD;
               -  or of a mother who has taken during pregnancy drugs or toxic drugs that affect&#xD;
                  the behavior of the newborn. (benzodiazepines, subutex, methadone, cocaine,&#xD;
                  heroin or cannabis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>29 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Boez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maternité Paul Gelé du CH de Roubaix</name>
      <address>
        <city>Roubaix</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteopathy</keyword>
  <keyword>cranial</keyword>
  <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/NCT03751787
org study id: 2008_43
secondary id: 2009-A00037-50
nct id: NCT03751787
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To evaluate, from the maternity stay, the interest of the cranial osteopathy in the reduction
      of the hyper irritability of the newborn and the improvement of the postural abnormalities
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
measure: Reduction of hyper irritability
time frame: at 28 days of life.
description: Reduction of hyper irritability will be done by evaluation from a clinical score,signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2:
Excessive and difficult to calm, insufficient sleep
postural asymmetry
difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling
Excessive regurgitation
measure: Reduction of hyper irritability
time frame: before any treatment, at 3 days after deliverance and at 28 days of life
description: Reduction of hyper irritability will be done by evaluation from a clinical score, signs of hyper irritability during stay in maternity or postural disorders: one of the following 4 criteria rated 3 or 4, or at least two of these rated criteria 2:
Excessive and difficult to calm, insufficient sleep
postural asymmetry
difficulties in feeding, ineffective suckling, including asymmetries (babies breastfeeding and refusing each other), difficulty suckling
Excessive regurgitation
arm group label: cranial osteopathy
arm group type: Experimental
description: The group will receive treatment with osteopathic cranial osteopathy
arm group label: comfort massage
arm group type: Placebo Comparator
description: The group will benefit from a placebo manipulation by an osteopathic student who has not yet been trained in cranial osteopathy.
intervention type: Other
intervention name: cranial osteopathy
description: two sessions at three weeks intervals
arm group label: cranial osteopathy
intervention type: Other
intervention name: comfort massage
description: manipulation, comfort massage, standardized and not affecting the skull
arm group label: comfort massage
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 29 Days
healthy volunteers: No
last name: Eric Boez, MD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No