Clinical trial NCT02224677: Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
Official title: Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniofacial Microsomia
Hemifacial Microsomia
Oculo-Auriculo-Vertebral-Syndrome
Goldenhar Syndrome
Microtia
Keywords: 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
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Children's Hospital Los Angeles
name: Children's Hospital of Philadelphia
name: University of North Carolina
name: Northwestern University
name: University of Illinois at Chicago
name: University of Washington
name: University of Pittsburgh
name: New York University
First posted: 2014-08-25
Enrollment: 417
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Neurodevelopmental Outcome Measures
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T2 study visit (~24 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T1 study visit (12-14 months of age)
measure: Neurodevelopmental Outcome Measures
timeFrame: T1 study visit (12-14 months of age)
measure: Neurodevelopmental Outcome Measures
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T1 study visit (12-14 months of age)
measure: Phenotypic Assessments
timeFrame: T2 study visit (~24 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Neurodevelopmental Outcome Measures
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
measure: Phenotypic Assessments
timeFrame: T3 study visit (~36 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Carrie L Heike, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Seattle Children's Hospital
name: Matthew L Speltz, PhD
role: PRINCIPAL_INVESTIGATOR
References: