CompletedNot Applicable

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

United States417 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range12 Months – 24 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Phenotypic Assessments

Timeframe: T1 study visit (12-14 months of age)

Phenotypic Assessments

Timeframe: T2 study visit (~24 months)

Neurodevelopmental Outcome Measures

Timeframe: T3 study visit (~36 months)

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments

Timeframe: T1 study visit (12-14 months of age)

Trial details

NCT IDNCT02224677

SponsorSeattle Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More Craniofacial Microsomia trials

Plain-language summary

Who can participate

Age range12 Months – 24 Months

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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:
✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Phenotypic Assessments

Timeframe: T1 study visit (12-14 months of age)

Phenotypic Assessments

Timeframe: T2 study visit (~24 months)

Neurodevelopmental Outcome Measures

Timeframe: T3 study visit (~36 months)

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Neurodevelopmental Outcome Measures

Timeframe: T1 study visit (12-14 months of age)

Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments

Timeframe: T1 study visit (12-14 months of age)