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

Microtia Clinical Trial

— CLOCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224677
• Other study ID #: NIDCR: 13-002-E
• Secondary ID: R01DE022438-01
• Status: Completed
• Start date: November 2013
• Est. completion date: August 31, 2019

Study information

• Verified date: April 2024
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Craniofacial Microsomia
• Fetal Growth Retardation
• Goldenhar Syndrome
• Hemifacial Microsomia
• Microtia
• Oculo-Auriculo-Vertebral-Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (10)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Children's Hospital Los Angeles, Children's Hospital of Philadelphia, National Institute of Dental and Craniofacial Research (NIDCR), New York University, Northwestern University, University of Illinois at Chicago, University of North Carolina, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopmental Outcome Measures	BSID-III Cognitive Index	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	2D photographs and video	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	Medical and Surgical History	T2 study visit (~24 months)
Primary	Neurodevelopmental Outcome Measures	BSID-III Cognitive Index	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	BSID-III Fine & Gross Motor	T1 study visit (12-14 months of age)
Primary	Neurodevelopmental Outcome Measures	PLS-V Auditory Comprehension	T1 study visit (12-14 months of age)
Primary	Neurodevelopmental Outcome Measures	PLS-V Expressive Language	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments	3D photographs,	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	Medical and Surgical History	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	Medical/dental chart abstraction	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	IT-MAIS: Auditory Assessment	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	OMENS rating from 2D images	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	Baby FACS observational protocol	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	Clinical Hearing Test	T1 study visit (12-14 months of age)
Primary	Phenotypic Assessments	IT-MAIS: Auditory Assessment	T2 study visit (~24 months)
Primary	Neurodevelopmental Outcome Measures	BSID-III Fine & Gross Motor	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	Leiter-R Brief IQ	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	Leiter-R Forward Memory	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	Leiter-R Sustained Attention	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	Leiter-R Associated Pairs	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	Leiter-R Matching	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	Leiter-R Picture Context	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	PLS-V Auditory Comprehension	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	PLS-V Expressive Language	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	NEPSY-II Phonological Processing	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	ITSEA Parent	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	ITSEA Teacher	T3 study visit (~36 months)
Primary	Neurodevelopmental Outcome Measures	Goldman-Fristoe Test of Articulation (GFTA-2)	T3 study visit (~36 months)
Primary	Phenotypic Assessments	2D photographs and video	T3 study visit (~36 months)
Primary	Phenotypic Assessments	3D photographs	T3 study visit (~36 months)
Primary	Phenotypic Assessments	Medical and Surgical History	T3 study visit (~36 months)
Primary	Phenotypic Assessments	Medical/dental chart abstraction	T3 study visit (~36 months)
Primary	Phenotypic Assessments	IT-MAIS: Auditory Assessment	T3 study visit (~36 months)
Primary	Phenotypic Assessments	OMENS rating from 2D images	T3 study visit (~36 months)
Primary	Phenotypic Assessments	Hearing Evaluation	T3 study visit (~36 months)
Primary	Phenotypic Assessments	Interview on willingness for future study	T3 study visit (~36 months)
Primary	Phenotypic Assessments	DNA collection (DNA)	T3 study visit (~36 months)