xml: <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/NCT06027645</url>
    </required_header>
    <id_info>
      <org_study_id>Premalocom2</org_study_id>
      <nct_id>NCT06027645</nct_id>
    </id_info>
    <brief_title>Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder</brief_title>
    <acronym>Premalocom2</acronym>
    <official_title>Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marianne Barbu-Roth</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ecole Pratique des Hautes Etudes</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Université Paris Cité</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>San Francisco State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Centre National de la Recherche Scientifique, France</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>
        Extreme prematurity is constantly increasing according to the World Health Organization.&#xD;
        However, methods to train premature infants at risk of disability is sorely lacking. The goal&#xD;
        of this project is to overcome this problem. In previous studies, the investigators&#xD;
        discovered that promoting the crawling of typical newborns on a mini skateboard, the&#xD;
        Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an&#xD;
        excellent way to stimulate infants' motor and locomotor development. This method is a&#xD;
        promising way to provide early interventions in infants at heightened risk for developmental&#xD;
        delay, such as premature infants.&#xD;
  &#xD;
        The specific objective of this study is to determine if early training in crawling on this&#xD;
        mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological&#xD;
        development in very premature infants identified as high risk for developmental delay.&#xD;
  &#xD;
        Methodology: The investigators will study and follow two groups of very premature infants&#xD;
        born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain&#xD;
        lesions.&#xD;
  &#xD;
        These infants will be recruited before their hospital discharge at the NICU. After their&#xD;
        discharge from the hospital, one group of infants will be trained at home by their parents&#xD;
        under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months&#xD;
        (Crawli group), and one group of infants will receive regular medical care (Control group).&#xD;
        All infants will be tested for: 1)their crawling proficiency on the Crawliskate at&#xD;
        term-equivalent age (just before training for the trained groups) and at 2 and 6 months&#xD;
        corrected age (CA, i.e., age determined from the date on which they should have been born),&#xD;
        2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control,&#xD;
        sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and&#xD;
        neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3,&#xD;
        Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more&#xD;
        ASQ-3 questionnaire will be provided at five years.&#xD;
  &#xD;
        Expected results: The first research hypothesis is that premature infants trained daily to&#xD;
        crawl (for two months after discharge from the NICU) will acquire proficient crawling&#xD;
        patterns and develop earlier and more effective motor and neuropsychological development than&#xD;
        premature infants who receive no training.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 29, 2021</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.</measure>
      <time_frame>12 months corrected age</time_frame>
      <description>The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.&#xD;
  A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study.&#xD;
  The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Amiel-Tison Neurological Assessment</measure>
      <time_frame>at 39-42 gestational age, 2, 9, 12 months corrected age</time_frame>
      <description>Infant neurological examination at study entry and after the training</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prechtl assessment</measure>
      <time_frame>at 39-42 gestational age and 2 months corrected age</time_frame>
      <description>General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Age and Stage questionnaire (ASQ) 3</measure>
      <time_frame>2, 6, 9, 12, 18, 28 corrected age and 5 years</time_frame>
      <description>Parental appreciation of their infant development in personal-social, communication, gross motor, fine motor and problem solving domain The minimal score is 0 and the maximal score is 60. A higher score means more advanced skills.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>2D &amp; 3D analysis of movement</measure>
      <time_frame>at 39-42 gestational age, 2, 6, 9, 12 months corrected age</time_frame>
      <description>2D &amp; 3D analysis of movement (head control, sitting, crawling, stepping, walking) using a motion capture system.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.</measure>
      <time_frame>2, 6, 9, 12, 24 months corrected age</time_frame>
      <description>The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.&#xD;
  A score can be obtained for each aspect. At 2, 6, 9, 12 and 24 months corrected age we only evaluate fine and gross motor scores. Note that the gross motor score obtained at 12 months corrected age is the primary outcome of our study but the fine motor score obtained at 12 months corrected age is also a secondary outcome.&#xD;
  The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Prematurity</condition>
    <condition>Extreme Prematurity</condition>
    <condition>Infant Development</condition>
    <condition>Brain Damage</condition>
    <condition>Motor and Developmental Delay</condition>
    <arm_group>
      <arm_group_label>Crawli Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants from the Crawli Group will benefit from the crawling stimulation intervention with a mini-skateboard (i.e. the crawliskate) in addition to usual care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group infants benefit from usual care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Crawling stimulation with a mini-skateboard (i.e. the crawliskate)</intervention_name>
      <description>Consists of 8 weeks of daily training. Infants benefit from a 10 minutes session everyday at home with either a trained therapist or his/her parents. Parents are trained by the therapist at the begining of the 8 weeks. During each session the infant is prone wrapped on a mini-skateboard (i.e. the crawliskate) and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the adult (therapist or parent).</description>
      <arm_group_label>Crawli Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Term between 24-26 GA or 26-32 GA with suspected brain lesion&#xD;
  &#xD;
            -  parental consent&#xD;
  &#xD;
            -  family living in intervention area&#xD;
  &#xD;
            -  good tolerance on the first crawliskate trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no bronchodysplasia defined by oxygen dependency after 36 GA&#xD;
  &#xD;
            -  no medical disease&#xD;
  &#xD;
            -  no limb deformity&#xD;
  &#xD;
            -  no karyotype anomaly&#xD;
  &#xD;
            -  no visual or auditory impairment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>39 Weeks</minimum_age>
      <maximum_age>42 Weeks</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marianne Barbu-Roth, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Centre National de la Recherche Scientifique, France</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Valérie Biran, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>APHP</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marianne Barbu-Roth, PhD</last_name>
      <phone>00336 18 61 09 15</phone>
      <email>barburoth@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Elodie Hinnekens, PT, PhD</last_name>
      <phone>00336 31 75 24 20</phone>
      <email>elodie.hinnekens@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cnrs Umr 8002</name>
        <address>
          <city>Paris</city>
          <state>Ile De France</state>
          <zip>75006</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marianne Barbu-Roth, PhD</last_name>
        <phone>0033618610915</phone>
        <email>barburoth@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Elodie Hinnekens, PT, PhD</last_name>
        <phone>0033631752420</phone>
        <email>elodie.hinnekens@gmail.com</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Hôpital Robert Debré</name>
        <address>
          <city>Paris</city>
          <state>Ile De France</state>
          <zip>75019</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Valérie Biran, MD, PhD</last_name>
        <phone>00336 88 48 48 85</phone>
        <email>valerie.biran@aphp.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hôpital Paris Saint-Joseph</name>
        <address>
          <city>Paris</city>
          <zip>75014</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Laurence Boujenah, MD</last_name>
        <email>lboujenah@ghpsj.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Centre National de la Recherche Scientifique, France</investigator_affiliation>
      <investigator_full_name>Marianne Barbu-Roth</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Prematurity</keyword>
    <keyword>Crawling</keyword>
    <keyword>Early intervention</keyword>
    <keyword>Motor development</keyword>
    <keyword>Locomotion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Injuries</mesh_term>
      <mesh_term>Premature Birth</mesh_term>
      <mesh_term>Neurodevelopmental Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>IPD will be made available upon reasonable request to corresponding author</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>From 2025 to 2030</ipd_time_frame>
      <ipd_access_criteria>IPD will be made available upon reasonable request to corresponding author</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027645
  org study id: Premalocom2
  nct id: NCT06027645
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Extreme prematurity is constantly increasing according to the World Health Organization.
        However, methods to train premature infants at risk of disability is sorely lacking. The goal
        of this project is to overcome this problem. In previous studies, the investigators
        discovered that promoting the crawling of typical newborns on a mini skateboard, the
        Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an
        excellent way to stimulate infants' motor and locomotor development. This method is a
        promising way to provide early interventions in infants at heightened risk for developmental
        delay, such as premature infants.
  
        The specific objective of this study is to determine if early training in crawling on this
        mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological
        development in very premature infants identified as high risk for developmental delay.
  
        Methodology: The investigators will study and follow two groups of very premature infants
        born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain
        lesions.
  
        These infants will be recruited before their hospital discharge at the NICU. After their
        discharge from the hospital, one group of infants will be trained at home by their parents
        under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months
        (Crawli group), and one group of infants will receive regular medical care (Control group).
        All infants will be tested for: 1)their crawling proficiency on the Crawliskate at
        term-equivalent age (just before training for the trained groups) and at 2 and 6 months
        corrected age (CA, i.e., age determined from the date on which they should have been born),
        2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control,
        sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and
        neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3,
        Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more
        ASQ-3 questionnaire will be provided at five years.
  
        Expected results: The first research hypothesis is that premature infants trained daily to
        crawl (for two months after discharge from the NICU) will acquire proficient crawling
        patterns and develop earlier and more effective motor and neuropsychological development than
        premature infants who receive no training.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.
  time frame: 12 months corrected age
  description: The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.
  A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study.
  The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
  measure: Amiel-Tison Neurological Assessment
  time frame: at 39-42 gestational age, 2, 9, 12 months corrected age
  description: Infant neurological examination at study entry and after the training
  measure: Prechtl assessment
  time frame: at 39-42 gestational age and 2 months corrected age
  description: General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress
  measure: Age and Stage questionnaire (ASQ) 3
  time frame: 2, 6, 9, 12, 18, 28 corrected age and 5 years
  description: Parental appreciation of their infant development in personal-social, communication, gross motor, fine motor and problem solving domain The minimal score is 0 and the maximal score is 60. A higher score means more advanced skills.
  measure: 2D & 3D analysis of movement
  time frame: at 39-42 gestational age, 2, 6, 9, 12 months corrected age
  description: 2D & 3D analysis of movement (head control, sitting, crawling, stepping, walking) using a motion capture system.
  measure: Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.
  time frame: 2, 6, 9, 12, 24 months corrected age
  description: The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain.
  A score can be obtained for each aspect. At 2, 6, 9, 12 and 24 months corrected age we only evaluate fine and gross motor scores. Note that the gross motor score obtained at 12 months corrected age is the primary outcome of our study but the fine motor score obtained at 12 months corrected age is also a secondary outcome.
  The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
  arm group label: Crawli Group
  arm group type: Experimental
  description: Participants from the Crawli Group will benefit from the crawling stimulation intervention with a mini-skateboard (i.e. the crawliskate) in addition to usual care
  arm group label: Control Group
  arm group type: No Intervention
  description: Control group infants benefit from usual care
  intervention type: Behavioral
  intervention name: Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
  description: Consists of 8 weeks of daily training. Infants benefit from a 10 minutes session everyday at home with either a trained therapist or his/her parents. Parents are trained by the therapist at the begining of the 8 weeks. During each session the infant is prone wrapped on a mini-skateboard (i.e. the crawliskate) and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the adult (therapist or parent).
  arm group label: Crawli Group
  criteria: 
  gender: All
  minimum age: 39 Weeks
  maximum age: 42 Weeks
  healthy volunteers: No
  last name: Marianne Barbu-Roth, PhD
  role: Study Chair
  affiliation: Centre National de la Recherche Scientifique, France
  last name: Valérie Biran, MD, PhD
  role: Principal Investigator
  affiliation: APHP
  last name: Marianne Barbu-Roth, PhD
  phone: 00336 18 61 09 15
  email: barburoth@gmail.com
  last name: Elodie Hinnekens, PT, PhD
  phone: 00336 31 75 24 20
  email: elodie.hinnekens@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor-Investigator
  investigator affiliation: Centre National de la Recherche Scientifique, France
  investigator full name: Marianne Barbu-Roth
  investigator title: Principal Investigator
  mesh term: Brain Injuries
  mesh term: Premature Birth
  mesh term: Neurodevelopmental Disorders
  sharing ipd: Yes
  ipd description: IPD will be made available upon reasonable request to corresponding author
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: From 2025 to 2030
  ipd access criteria: IPD will be made available upon reasonable request to corresponding author