Status:
COMPLETED
Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
Lead Sponsor:
Seattle Children's Hospital
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Children's Hospital Los Angeles
Conditions:
Craniofacial Microsomia
Hemifacial Microsomia
Eligibility:
All Genders
12-24 years
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 evaluati...
Eligibility Criteria
Inclusion
- We are currently looking to enroll children with craniofacial microsomia through ClinicalTrials.gov
- Children with Craniofacial Microsomia:
- 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).
- 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
- Infant participant has been diagnosed by a regional craniofacial team.
- Legal guardian will provide written parental permission and informed consent prior to participation in study.
- 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
- Children with Craniofacial Microsomia:
- 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).
- Subject has abnormal chromosome studies (karyotype)
- Subject has a major medical or neurological condition that prevents participation in the study (e.g., cancer, cerebral palsy) at time of recruitment
- Subject was born before 34 weeks estimated gestational age
- Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- Sibling already participating in the CLOCK study
- Subject's consenting parent does not speak English or Spanish
- Parents of Children with Craniofacial Microsomia
- Anything that would preclude the subject's full compliance with or completion of the study.
- Subject does not speak English or Spanish
Key Trial Info
Start Date :
November 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT02224677
Start Date
November 1 2013
End Date
August 31 2019
Last Update
April 19 2024
Active Locations (5)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60607
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 90027