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

This study is currently recruiting participants.
Verified December 2015 by Carrie Heike, Seattle Children's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02224677
First Posted: August 25, 2014
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
Children's Hospital Los Angeles
Children's Hospital of Philadelphia
University of North Carolina
Northwestern University
University of Illinois at Chicago
University of Washington
University of Pittsburgh
New York University
Information provided by (Responsible Party):
Carrie Heike, Seattle Children's Hospital
  Purpose
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.

Condition
Craniofacial Microsomia Hemifacial Microsomia Oculo-Auriculo-Vertebral-Syndrome Goldenhar Syndrome Microtia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)

Resource links provided by NLM:


Further study details as provided by Carrie Heike, Seattle Children's Hospital:

Primary Outcome Measures:
  • 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

  • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    Medical/dental chart abstraction

  • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    IT-MAIS: Auditory Assessment

  • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    OMENS rating from 2D images

  • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    Baby FACS observational protocol

  • Phenotypic Assessments [ Time Frame: T1 study visit (12-14 months of age) ]
    Clinical Hearing Test

  • Phenotypic Assessments [ Time Frame: T2 study visit (~24 months) ]
    IT-MAIS: Auditory Assessment

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    BSID-III Fine & Gross Motor

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    Leiter-R Brief IQ

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    Leiter-R Forward Memory

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    Leiter-R Sustained Attention

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    Leiter-R Associated Pairs

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    Leiter-R Matching

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    Leiter-R Picture Context

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    PLS-V Auditory Comprehension

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    PLS-V Expressive Language

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    NEPSY-II Phonological Processing

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    ITSEA Parent

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    ITSEA Teacher

  • Neurodevelopmental Outcome Measures [ Time Frame: T3 study visit (~36 months) ]
    Goldman-Fristoe Test of Articulation (GFTA-2)

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    2D photographs and video

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    3D photographs

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    Medical and Surgical History

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    Medical/dental chart abstraction

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    IT-MAIS: Auditory Assessment

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    OMENS rating from 2D images

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    Hearing Evaluation

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    Interview on willingness for future study

  • Phenotypic Assessments [ Time Frame: T3 study visit (~36 months) ]
    DNA collection (DNA)


Biospecimen Retention:   Samples With DNA
Saliva

Estimated Enrollment: 685
Study Start Date: November 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children with Craniofacial Microsomia
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.
Children without Craniofacial Microsomia
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.
Parents of Children with Craniofacial Microsomia
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.
Parents of Children without Craniofacial Microsomia
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.
Teacher/Day Care Provider
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with and without craniofacial microsomia will be drawn from outpatient clinics, medical centers, and local pediatric practices near performance sites and local pediatric practices. Cases will be approached in their first 24 months by either a member of their craniofacial team, a member of the CLOCK study team, or one of their treating providers. Cases may find out about the study through ClinicalTrials.gov. Controls will initially be approached through a treating provider, a member of the CLOCK team, or through an announcement about the study.
Criteria

We are currently looking to enroll children with craniofacial microsomia through ClinicalTrials.gov

Inclusion Criteria:

Children with Craniofacial Microsomia:

  1. Male or female infant participant is between 12 months and 24 months of age, or corrected age (for some infants born prior to their due date).
  2. Infant participant has diagnosis of at least one of the following conditions:

    • Microtia
    • Anotia
    • Facial asymmetry AND Preauricular tag(s)
    • Facial asymmetry AND Facial tag(s)
    • Facial asymmetry AND Epibulbar dermoid
    • Facial asymmetry AND Macrostomia (i.e., lateral cleft)
    • Preauricular tag AND Epibulbar dermoid
    • Preauricular tag AND Macrostomia
    • Facial tag AND Epibulbar dermoid
    • Macrostomia AND Epibulbar dermoid
  3. Infant participant has been diagnosed by a regional craniofacial team.
  4. Legal guardian will provide written parental permission and informed consent prior to participation in study.
  5. Legal guardian is willing to comply with all study procedures and be available for the duration of the study through Time 3.

Parents of Children with Craniofacial Microsomia:

  • able to provide written consent for study participation,
  • willing to comply with all study procedures and
  • interested in participating in the entire study through Time 3.

Exclusion Criteria:

Children with Craniofacial Microsomia:

  1. Subject is diagnosed with a known syndrome that involves microtia and/or underdevelopment of the jaw (Townes-Brocks, Treacher Collins, branchiootorenal, Nager, or Miller syndromes).
  2. Subject has abnormal chromosome studies (karyotype)
  3. Subject has a major medical or neurological condition that prevents participation in the study (e.g., cancer, cerebral palsy) at time of recruitment
  4. Subject was born before 34 weeks estimated gestational age
  5. Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
  6. Sibling already participating in the CLOCK study
  7. Subject's consenting parent does not speak English or Spanish

Parents of Children with Craniofacial Microsomia

  1. Anything that would preclude the subject's full compliance with or completion of the study.
  2. Subject does not speak English or Spanish
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224677


Contacts
Contact: Amber Sand 206-884-1844 amber.sand@seattlechildrens.org
Contact: Sharman Conner 206-887-4924 sharman.conner@seattlechildrens.org

Locations
United States, California
Children's Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: CLOCK Study       CLOCK@seattlechildrens.org   
Principal Investigator: Alexis Johns, PhD         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60607
Contact: CLOCK Study       CLOCK@seattlechildrens.org   
Principal Investigator: Kathleen Kapp-Simon, PhD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: CLOCK Study       CLOCK@seattlechildrens.org   
Principal Investigator: Amelia Drake, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Active, not recruiting
Philadelphia, Pennsylvania, United States, 90027
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98101
Contact: Amber Sand    206-884-1844    amber.sand@seattlechildrens.org   
Contact: Sharman Conner    206-987-4924    sharman.conner@seattlechildrens.org   
Principal Investigator: Carrie L Heike, MD, MS         
Principal Investigator: Matthew L Speltz, PhD         
Sponsors and Collaborators
Seattle Children's Hospital
National Institute of Dental and Craniofacial Research (NIDCR)
Children's Hospital Los Angeles
Children's Hospital of Philadelphia
University of North Carolina
Northwestern University
University of Illinois at Chicago
University of Washington
University of Pittsburgh
New York University
Investigators
Principal Investigator: Carrie L Heike, MD, MS Seattle Children's Hospital
Principal Investigator: Matthew L Speltz, PhD Seattle Children's Hospital
  More Information

Responsible Party: Carrie Heike, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02224677     History of Changes
Other Study ID Numbers: NIDCR: 13-002-E
R01DE022438-01 ( U.S. NIH Grant/Contract )
First Submitted: August 19, 2014
First Posted: August 25, 2014
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Carrie Heike, Seattle Children's Hospital:
CFM
facial asymmetry
skin tag
facial tag
missing ear
small ear
anotia
microtia
epibulbar dermoid
coloboma
macrostomia
lateral cleft
infant
toddler
baby
neurodevelopment
cognition
socialization

Additional relevant MeSH terms:
Syndrome
Fetal Growth Retardation
Congenital Microtia
Goldenhar Syndrome
Disease
Pathologic Processes
Fetal Diseases
Pregnancy Complications
Growth Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Congenital Abnormalities
Mandibulofacial Dysostosis
Craniofacial Dysostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities