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

Status:	Recruiting
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	Any
Updated:	4/21/2016
Start Date:	November 2013
End Date:	August 2017
Contact:	Amber Sand
Email:	amber.sand@seattlechildrens.org
Phone:	206-884-1844

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.

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

We found this trial at

sites

Univ of North Carolina

Chapel Hill, North Carolina 27599

(919) 962-2211