<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/NCT03780920</url>
  </required_header>
  <id_info>
    <org_study_id>UF 7660</org_study_id>
    <nct_id>NCT03780920</nct_id>
  </id_info>
  <brief_title>Preventive Osteopathic Treatment of Plagiocephaly</brief_title>
  <acronym>TOPP PLAGIO</acronym>
  <official_title>Interest of an Early Osteopathic Treatment in Infants in the Prevention of Cranial Deformations : Positional Plagiocephaly and Brachycephaly.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for&#xD;
      pediatric consultation, which has increased significantly since the recommendation to lay&#xD;
      babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern&#xD;
      for parents about their impact on psychomotor development and the aesthetic risk of&#xD;
      deformity. The High Authority for Health (HAS) will soon put in place recommendations with a&#xD;
      fact sheet for health professionals and the public. The aim of this research is to study&#xD;
      whether early treatment of rotation disorders and hypertonia in newborns by manual&#xD;
      osteopathic techniques would prevent the occurrence of positional deformities of the skull.&#xD;
&#xD;
      The main objective is to evaluate the effectiveness of an early osteopathic treatment on the&#xD;
      rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.&#xD;
&#xD;
      the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment&#xD;
      on the quality of life of the child at 4 months.&#xD;
&#xD;
      Methodology: Controlled, randomized monocentric two-arm parallel study between (1)&#xD;
      osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18&#xD;
      months and the follow-up period is 4 months.&#xD;
&#xD;
      Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group&#xD;
      will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of&#xD;
      3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and&#xD;
      stimulation advice.&#xD;
&#xD;
      The perspectives are:&#xD;
&#xD;
        -  the decrease in the prevalence of CPP after early osteopathic treatment.&#xD;
&#xD;
        -  Defining a decision algorithm for early osteopathic treatment.&#xD;
&#xD;
        -  Subject to recommendations on the indication of early osteopathic treatment in neonates&#xD;
           at risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">January 21, 2022</completion_date>
  <primary_completion_date type="Actual">January 21, 2022</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>Prevention</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Positionnal skull deformation : plagiocephaly and brachycephaly</measure>
    <time_frame>four month</time_frame>
    <description>cranial vault asymetry index and cranial index measured with caliper between the age of 3 to 10 days and at 4 months measured blind of the randomization arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire QUALIN</measure>
    <time_frame>fourth month</time_frame>
    <description>the&quot;questionnaire QUALIN&quot; is a quality of life assessment questinniare for infant under 3 months of age, valided in Europe(French, Spanish, English and Italian)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Positilonal Deformation of the Skull</condition>
  <condition>Head Turn Preference</condition>
  <condition>Axial Hypertony</condition>
  <arm_group>
    <arm_group_label>Osteopathic treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>manual therapy/osteopathy</intervention_name>
    <description>In this group, children will benefit from early osteopathic treatment over a period ranging from the third day to 4 months. The number of sessions will not be fixed, on average, 3 sessions will be carried out during this period at the University Hospital of Montpellier.&#xD;
The duration of the session will be between 20 minutes to 30 or even 40 minutes</description>
    <arm_group_label>Osteopathic treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newborn baby aged 3 days and until the maternity leave&#xD;
&#xD;
          -  Newborn with at least one risk factor for cranial deformity:&#xD;
&#xD;
               -  Newborn who received instrumental vaginal delivery.&#xD;
&#xD;
               -  Newborn presenting:&#xD;
&#xD;
                    -  a preferential side,&#xD;
&#xD;
                    -  global axial hypertonia,&#xD;
&#xD;
                    -  Localized suboccipital hypertonia&#xD;
&#xD;
               -  Newborn presenting:&#xD;
&#xD;
                    -  cranial deformity at birth,&#xD;
&#xD;
                    -  a deformation of the face,&#xD;
&#xD;
                    -  deformity of the trunk in scoliosis, comma or hyperextension&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborn with congenital muscular torticollis (managed directly in physiotherapy)&#xD;
&#xD;
               -  Premature neonate (&lt;37SA)&#xD;
&#xD;
               -  Newborn with a malformation pathology&#xD;
&#xD;
               -  Newborn with craniosynostosis.&#xD;
&#xD;
               -  Newborn with a contraindication to the practice of osteopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Days</minimum_age>
    <maximum_age>11 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume CAPTIER, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <state>Hérault</state>
        <zip>34000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</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>Plagiocephaly</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/NCT03780920
org study id: UF 7660
nct id: NCT03780920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for
      pediatric consultation, which has increased significantly since the recommendation to lay
      babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern
      for parents about their impact on psychomotor development and the aesthetic risk of
      deformity. The High Authority for Health (HAS) will soon put in place recommendations with a
      fact sheet for health professionals and the public. The aim of this research is to study
      whether early treatment of rotation disorders and hypertonia in newborns by manual
      osteopathic techniques would prevent the occurrence of positional deformities of the skull.

      The main objective is to evaluate the effectiveness of an early osteopathic treatment on the
      rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk.

      the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment
      on the quality of life of the child at 4 months.

      Methodology: Controlled, randomized monocentric two-arm parallel study between (1)
      osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18
      months and the follow-up period is 4 months.

      Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group
      will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of
      3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and
      stimulation advice.

      The perspectives are:

        -  the decrease in the prevalence of CPP after early osteopathic treatment.

        -  Defining a decision algorithm for early osteopathic treatment.

        -  Subject to recommendations on the indication of early osteopathic treatment in neonates
           at risk.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Investigator, Outcomes Assessor)
measure: Positionnal skull deformation : plagiocephaly and brachycephaly
time frame: four month
description: cranial vault asymetry index and cranial index measured with caliper between the age of 3 to 10 days and at 4 months measured blind of the randomization arm
measure: Questionnaire QUALIN
time frame: fourth month
description: the"questionnaire QUALIN" is a quality of life assessment questinniare for infant under 3 months of age, valided in Europe(French, Spanish, English and Italian)
arm group label: Osteopathic treatment
arm group type: Active Comparator
arm group label: Control group
arm group type: No Intervention
intervention type: Procedure
intervention name: manual therapy/osteopathy
description: In this group, children will benefit from early osteopathic treatment over a period ranging from the third day to 4 months. The number of sessions will not be fixed, on average, 3 sessions will be carried out during this period at the University Hospital of Montpellier.
The duration of the session will be between 20 minutes to 30 or even 40 minutes
arm group label: Osteopathic treatment
criteria: 
gender: All
minimum age: 3 Days
maximum age: 11 Days
healthy volunteers: No
last name: Guillaume CAPTIER, Pr
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Plagiocephaly