Clinical Trial: Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)

Brief Summary: 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.

Detailed Summary:
Sponsor: Seattle Children's Hospital

Current Primary Outcome:

  • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
    BSID-III Cognitive Index
  • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    2D photographs and video
  • Phenotypic Assessments [ Time Frame: T2 study visit (~24 months) ]
    Medical and Surgical History
  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    BSID-III Cognitive Index
  • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
    BSID-III Fine & Gross Motor
  • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
    PLS-V Auditory Comprehension
  • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
    PLS-V Expressive Language
  • Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    3D photographs,
  • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    Medical and Surgical History

  • Original Primary Outcome:

    • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
      BSID-III Cognitive Index
    • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
      2D photographs and video
    • Phenotypic Assessments [ Time Frame: T2 study visit (~24 months) ]
      Medical and Surgical History
    • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
      BSID-III Cognitive Index
    • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
      BSID-III Fine & Gross Motor
    • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
      PLS-V Auditory Comprehension
    • Neurodevelopmental Outcome Measures [ Time Frame: T1 study visit (12-14 months of age) ]
      PLS-V Expressive Language
    • Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
      3D photographs,
    • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
      Medical and Surgical History

    • Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: Seattle Children's Hospital

      Dates:
      Date Received: August 19, 2014
      Date Started: November 2013
      Date Completion: August 2017
      Last Updated: December 11, 2015
      Last Verified: December 2015