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Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK) | Clinical Trials | Clareo Health

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

NCT02224677•Seattle Children's Hospital

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.

Eligibility

Age

1 - 2 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•We are currently looking to enroll children with craniofacial microsomia through ClinicalTrials.gov
•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)
+11 more criteria

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.
+1 more criteria

Locations (5)

Children's Hospital Los Angeles

Los Angeles, California, United States

University of Illinois at Chicago

Chicago, Illinois, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Seattle Children's Hospital

Seattle, Washington, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

August 31, 2019

Completion Date

August 31, 2019

Last Updated

April 19, 2024

Enrollment

417

ACTUAL participants

Conditions

Craniofacial MicrosomiaHemifacial MicrosomiaOculo-Auriculo-Vertebral-SyndromeGoldenhar SyndromeMicrotia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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