<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/NCT02224677</url>
  </required_header>
  <id_info>
    <org_study_id>NIDCR: 13-002-E</org_study_id>
    <secondary_id>R01DE022438-01</secondary_id>
    <nct_id>NCT02224677</nct_id>
  </id_info>
  <brief_title>Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)</brief_title>
  <acronym>CLOCK</acronym>
  <official_title>Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Dental and Craniofacial Research (NIDCR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New York University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multi-center, longitudinal cohort study of 125 infants with craniofacial&#xD;
      microsomia (CFM) and 100 infants without craniofacial anomalies. Participants will undergo a&#xD;
      series of evaluations between 0-3 years of age to comprehensively evaluate the developmental&#xD;
      status of infants and toddlers with CFM. This research design will also explore specific&#xD;
      pathways by which CFM may lead to certain outcomes. Specifically, the study explores (1) the&#xD;
      longitudinal relations between facial asymmetry and emotion-related facial movements and&#xD;
      socialization; and (2) associations among ear malformations, hearing and speech deficits and&#xD;
      cognitive outcomes. Results of this research will ultimately lead to future investigations&#xD;
      that assess new interventions and corresponding changes in current standards of care for&#xD;
      children with CFM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2013</start_date>
  <completion_date type="Anticipated">August 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>BSID-III Cognitive Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>2D photographs and video</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T2 study visit (~24 months)</time_frame>
    <description>Medical and Surgical History</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>BSID-III Cognitive Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>BSID-III Fine &amp; Gross Motor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>PLS-V Auditory Comprehension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>PLS-V Expressive Language</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>3D photographs,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>Medical and Surgical History</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>Medical/dental chart abstraction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>IT-MAIS: Auditory Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>OMENS rating from 2D images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>Baby FACS observational protocol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T1 study visit (12-14 months of age)</time_frame>
    <description>Clinical Hearing Test</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T2 study visit (~24 months)</time_frame>
    <description>IT-MAIS: Auditory Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>BSID-III Fine &amp; Gross Motor</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Leiter-R Brief IQ</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Leiter-R Forward Memory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Leiter-R Sustained Attention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Leiter-R Associated Pairs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Leiter-R Matching</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Leiter-R Picture Context</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>PLS-V Auditory Comprehension</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>PLS-V Expressive Language</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>NEPSY-II Phonological Processing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>ITSEA Parent</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>ITSEA Teacher</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurodevelopmental Outcome Measures</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Goldman-Fristoe Test of Articulation (GFTA-2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>2D photographs and video</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>3D photographs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Medical and Surgical History</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Medical/dental chart abstraction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>IT-MAIS: Auditory Assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>OMENS rating from 2D images</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Hearing Evaluation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>Interview on willingness for future study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phenotypic Assessments</measure>
    <time_frame>T3 study visit (~36 months)</time_frame>
    <description>DNA collection (DNA)</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">685</enrollment>
  <condition>Craniofacial Microsomia</condition>
  <condition>Hemifacial Microsomia</condition>
  <condition>Oculo-Auriculo-Vertebral-Syndrome</condition>
  <condition>Goldenhar Syndrome</condition>
  <condition>Microtia</condition>
  <arm_group>
    <arm_group_label>Children with Craniofacial Microsomia</arm_group_label>
    <description>125 children with craniofacial microsomia will be asked to come in for two study visits - when they are about 12 months old and again when they are about 36 months old. Procedures for children at the first visit include: assessment of development, video, photographs, and a hearing evaluation. Procedures for the final study visit include: assessment of development, photographs (2D &amp; 3D), video, saliva sample, hearing evaluation, speech assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Children without Craniofacial Microsomia</arm_group_label>
    <description>Please note: we are not recruiting this group through ClinicalTrials.gov 100 children without craniofacial microsomia will be asked to come in for two study visits - when they are about 12 months old and again when they are about 36 months old. Procedures for the first visit include: assessment of development, video, and photographs. Procedures for the final study visit include: assessment of development, photographs (2D &amp; 3D), video, and speech assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents of Children with Craniofacial Microsomia</arm_group_label>
    <description>125-250 parents of children with craniofacial microsomia will be asked to complete three visits - when their child is about 12 months old, 24 months old, and 36 months old. Parents will be asked to complete an interview at the first visit. The second visit consists of a telephone interview where parents will be asked about their child's hearing and health history. At the final study visit, parents will be asked to complete more questionnaires, have their picture taken, and donate saliva.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parents of Children without Craniofacial Microsomia</arm_group_label>
    <description>Please note: we are not recruiting this group through ClinicalTrials.gov 100 parents of children without craniofacial microsomia will be asked to complete three visits - when their child is about 12 months old, 24 months old, and 36 months old. Parents will be asked to complete an interview at the first visit. The second visit consists of a telephone interview where parents will be asked about their child's hearing and health history. At the final study visit, parents will be asked to complete questionnaires and an interview.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Teacher/Day Care Provider</arm_group_label>
    <description>When the children participants are around 36 months old, we will ask parents for permission to contact their child's teacher/day care provider. We would like the teacher/day care provider to fill out a questionnaire.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Children with and without craniofacial microsomia will be drawn from outpatient clinics,&#xD;
        medical centers, and local pediatric practices near performance sites and local pediatric&#xD;
        practices. Cases will be approached in their first 24 months by either a member of their&#xD;
        craniofacial team, a member of the CLOCK study team, or one of their treating providers.&#xD;
        Cases may find out about the study through ClinicalTrials.gov. Controls will initially be&#xD;
        approached through a treating provider, a member of the CLOCK team, or through an&#xD;
        announcement about the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        We are currently looking to enroll children with craniofacial microsomia through&#xD;
        ClinicalTrials.gov&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        Children with Craniofacial Microsomia:&#xD;
&#xD;
          1. Male or female infant participant is between 12 months and 24 months of age, or&#xD;
             corrected age (for some infants born prior to their due date).&#xD;
&#xD;
          2. Infant participant has diagnosis of at least one of the following conditions:&#xD;
&#xD;
               -  Microtia&#xD;
&#xD;
               -  Anotia&#xD;
&#xD;
               -  Facial asymmetry AND Preauricular tag(s)&#xD;
&#xD;
               -  Facial asymmetry AND Facial tag(s)&#xD;
&#xD;
               -  Facial asymmetry AND Epibulbar dermoid&#xD;
&#xD;
               -  Facial asymmetry AND Macrostomia (i.e., lateral cleft)&#xD;
&#xD;
               -  Preauricular tag AND Epibulbar dermoid&#xD;
&#xD;
               -  Preauricular tag AND Macrostomia&#xD;
&#xD;
               -  Facial tag AND Epibulbar dermoid&#xD;
&#xD;
               -  Macrostomia AND Epibulbar dermoid&#xD;
&#xD;
          3. Infant participant has been diagnosed by a regional craniofacial team.&#xD;
&#xD;
          4. Legal guardian will provide written parental permission and informed consent prior to&#xD;
             participation in study.&#xD;
&#xD;
          5. Legal guardian is willing to comply with all study procedures and be available for the&#xD;
             duration of the study through Time 3.&#xD;
&#xD;
        Parents of Children with Craniofacial Microsomia:&#xD;
&#xD;
          -  able to provide written consent for study participation,&#xD;
&#xD;
          -  willing to comply with all study procedures and&#xD;
&#xD;
          -  interested in participating in the entire study through Time 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children with Craniofacial Microsomia:&#xD;
&#xD;
          1. Subject is diagnosed with a known syndrome that involves microtia and/or&#xD;
             underdevelopment of the jaw (Townes-Brocks, Treacher Collins, branchiootorenal, Nager,&#xD;
             or Miller syndromes).&#xD;
&#xD;
          2. Subject has abnormal chromosome studies (karyotype)&#xD;
&#xD;
          3. Subject has a major medical or neurological condition that prevents participation in&#xD;
             the study (e.g., cancer, cerebral palsy) at time of recruitment&#xD;
&#xD;
          4. Subject was born before 34 weeks estimated gestational age&#xD;
&#xD;
          5. Anything that would place the subject at increased risk or preclude the subject's full&#xD;
             compliance with or completion of the study.&#xD;
&#xD;
          6. Sibling already participating in the CLOCK study&#xD;
&#xD;
          7. Subject's consenting parent does not speak English or Spanish&#xD;
&#xD;
        Parents of Children with Craniofacial Microsomia&#xD;
&#xD;
          1. Anything that would preclude the subject's full compliance with or completion of the&#xD;
             study.&#xD;
&#xD;
          2. Subject does not speak English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carrie L Heike, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew L Speltz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amber Sand</last_name>
    <phone>206-884-1844</phone>
    <email>amber.sand@seattlechildrens.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sharman Conner</last_name>
    <phone>206-887-4924</phone>
    <email>sharman.conner@seattlechildrens.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CLOCK Study</last_name>
      <email>CLOCK@seattlechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Alexis Johns, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CLOCK Study</last_name>
      <email>CLOCK@seattlechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Kathleen Kapp-Simon, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>CLOCK Study</last_name>
      <email>CLOCK@seattlechildrens.org</email>
    </contact>
    <investigator>
      <last_name>Amelia Drake, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amber Sand</last_name>
      <phone>206-884-1844</phone>
      <email>amber.sand@seattlechildrens.org</email>
    </contact>
    <contact_backup>
      <last_name>Sharman Conner</last_name>
      <phone>206-987-4924</phone>
      <email>sharman.conner@seattlechildrens.org</email>
    </contact_backup>
    <investigator>
      <last_name>Carrie L Heike, MD, MS</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Matthew L Speltz, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>December 11, 2015</last_update_submitted>
  <last_update_submitted_qc>December 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Carrie Heike</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>CFM</keyword>
  <keyword>facial asymmetry</keyword>
  <keyword>skin tag</keyword>
  <keyword>facial tag</keyword>
  <keyword>missing ear</keyword>
  <keyword>small ear</keyword>
  <keyword>anotia</keyword>
  <keyword>microtia</keyword>
  <keyword>epibulbar dermoid</keyword>
  <keyword>coloboma</keyword>
  <keyword>macrostomia</keyword>
  <keyword>lateral cleft</keyword>
  <keyword>infant</keyword>
  <keyword>toddler</keyword>
  <keyword>baby</keyword>
  <keyword>neurodevelopment</keyword>
  <keyword>cognition</keyword>
  <keyword>socialization</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Goldenhar Syndrome</mesh_term>
    <mesh_term>Congenital Microtia</mesh_term>
    <mesh_term>Fetal Growth Retardation</mesh_term>
    <mesh_term>Syndrome</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/NCT02224677
org study id: NIDCR: 13-002-E
secondary id: R01DE022438-01
nct id: NCT02224677
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This study is a multi-center, longitudinal cohort study of 125 infants with craniofacial
      microsomia (CFM) and 100 infants without craniofacial anomalies. Participants will undergo a
      series of evaluations between 0-3 years of age to comprehensively evaluate the developmental
      status of infants and toddlers with CFM. This research design will also explore specific
      pathways by which CFM may lead to certain outcomes. Specifically, the study explores (1) the
      longitudinal relations between facial asymmetry and emotion-related facial movements and
      socialization; and (2) associations among ear malformations, hearing and speech deficits and
      cognitive outcomes. Results of this research will ultimately lead to future investigations
      that assess new interventions and corresponding changes in current standards of care for
      children with CFM.
observational model: Case-Control
time perspective: Prospective
measure: Neurodevelopmental Outcome Measures
time frame: T1 study visit (12-14 months of age)
description: BSID-III Cognitive Index
measure: Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: 2D photographs and video
measure: Phenotypic Assessments
time frame: T2 study visit (~24 months)
description: Medical and Surgical History
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: BSID-III Cognitive Index
measure: Neurodevelopmental Outcome Measures
time frame: T1 study visit (12-14 months of age)
description: BSID-III Fine & Gross Motor
measure: Neurodevelopmental Outcome Measures
time frame: T1 study visit (12-14 months of age)
description: PLS-V Auditory Comprehension
measure: Neurodevelopmental Outcome Measures
time frame: T1 study visit (12-14 months of age)
description: PLS-V Expressive Language
measure: Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: 3D photographs,
measure: Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: Medical and Surgical History
measure: Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: Medical/dental chart abstraction
measure: Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: IT-MAIS: Auditory Assessment
measure: Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: OMENS rating from 2D images
measure: Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: Baby FACS observational protocol
measure: Phenotypic Assessments
time frame: T1 study visit (12-14 months of age)
description: Clinical Hearing Test
measure: Phenotypic Assessments
time frame: T2 study visit (~24 months)
description: IT-MAIS: Auditory Assessment
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: BSID-III Fine & Gross Motor
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: Leiter-R Brief IQ
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: Leiter-R Forward Memory
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: Leiter-R Sustained Attention
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: Leiter-R Associated Pairs
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: Leiter-R Matching
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: Leiter-R Picture Context
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: PLS-V Auditory Comprehension
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: PLS-V Expressive Language
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: NEPSY-II Phonological Processing
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: ITSEA Parent
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: ITSEA Teacher
measure: Neurodevelopmental Outcome Measures
time frame: T3 study visit (~36 months)
description: Goldman-Fristoe Test of Articulation (GFTA-2)
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: 2D photographs and video
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: 3D photographs
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: Medical and Surgical History
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: Medical/dental chart abstraction
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: IT-MAIS: Auditory Assessment
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: OMENS rating from 2D images
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: Hearing Evaluation
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: Interview on willingness for future study
measure: Phenotypic Assessments
time frame: T3 study visit (~36 months)
description: DNA collection (DNA)
arm group label: Children with Craniofacial Microsomia
description: 125 children with craniofacial microsomia will be asked to come in for two study visits - when they are about 12 months old and again when they are about 36 months old. Procedures for children at the first visit include: assessment of development, video, photographs, and a hearing evaluation. Procedures for the final study visit include: assessment of development, photographs (2D & 3D), video, saliva sample, hearing evaluation, speech assessment.
arm group label: Children without Craniofacial Microsomia
description: Please note: we are not recruiting this group through ClinicalTrials.gov 100 children without craniofacial microsomia will be asked to come in for two study visits - when they are about 12 months old and again when they are about 36 months old. Procedures for the first visit include: assessment of development, video, and photographs. Procedures for the final study visit include: assessment of development, photographs (2D & 3D), video, and speech assessment.
arm group label: Parents of Children with Craniofacial Microsomia
description: 125-250 parents of children with craniofacial microsomia will be asked to complete three visits - when their child is about 12 months old, 24 months old, and 36 months old. Parents will be asked to complete an interview at the first visit. The second visit consists of a telephone interview where parents will be asked about their child's hearing and health history. At the final study visit, parents will be asked to complete more questionnaires, have their picture taken, and donate saliva.
arm group label: Parents of Children without Craniofacial Microsomia
description: Please note: we are not recruiting this group through ClinicalTrials.gov 100 parents of children without craniofacial microsomia will be asked to complete three visits - when their child is about 12 months old, 24 months old, and 36 months old. Parents will be asked to complete an interview at the first visit. The second visit consists of a telephone interview where parents will be asked about their child's hearing and health history. At the final study visit, parents will be asked to complete questionnaires and an interview.
arm group label: Teacher/Day Care Provider
description: When the children participants are around 36 months old, we will ask parents for permission to contact their child's teacher/day care provider. We would like the teacher/day care provider to fill out a questionnaire.
Saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 24 Months
healthy volunteers: No
last name: Carrie L Heike, MD, MS
role: Principal Investigator
affiliation: Seattle Children's Hospital
last name: Matthew L Speltz, PhD
role: Principal Investigator
affiliation: Seattle Children's Hospital
last name: Amber Sand
phone: 206-884-1844
email: amber.sand@seattlechildrens.org
last name: Sharman Conner
phone: 206-887-4924
email: sharman.conner@seattlechildrens.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Carrie Heike
investigator title: Principal Investigator
mesh term: Goldenhar Syndrome
mesh term: Congenital Microtia
mesh term: Fetal Growth Retardation
mesh term: Syndrome