Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
CLOCK
2 other identifiers
observational
417
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 19, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedApril 19, 2024
April 1, 2024
5.8 years
August 19, 2014
April 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (37)
Neurodevelopmental Outcome Measures
BSID-III Cognitive Index
T1 study visit (12-14 months of age)
Phenotypic Assessments
2D photographs and video
T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical and Surgical History
T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
BSID-III Cognitive Index
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
BSID-III Fine \& Gross Motor
T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
PLS-V Auditory Comprehension
T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
PLS-V Expressive Language
T1 study visit (12-14 months of age)
Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
3D photographs,
T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical and Surgical History
T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical/dental chart abstraction
T1 study visit (12-14 months of age)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
T1 study visit (12-14 months of age)
Phenotypic Assessments
OMENS rating from 2D images
T1 study visit (12-14 months of age)
Phenotypic Assessments
Baby FACS observational protocol
T1 study visit (12-14 months of age)
Phenotypic Assessments
Clinical Hearing Test
T1 study visit (12-14 months of age)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
BSID-III Fine \& Gross Motor
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Brief IQ
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Forward Memory
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Sustained Attention
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Associated Pairs
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Matching
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Picture Context
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
PLS-V Auditory Comprehension
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
PLS-V Expressive Language
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
NEPSY-II Phonological Processing
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
ITSEA Parent
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
ITSEA Teacher
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Goldman-Fristoe Test of Articulation (GFTA-2)
T3 study visit (~36 months)
Phenotypic Assessments
2D photographs and video
T3 study visit (~36 months)
Phenotypic Assessments
3D photographs
T3 study visit (~36 months)
Phenotypic Assessments
Medical and Surgical History
T3 study visit (~36 months)
Phenotypic Assessments
Medical/dental chart abstraction
T3 study visit (~36 months)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
T3 study visit (~36 months)
Phenotypic Assessments
OMENS rating from 2D images
T3 study visit (~36 months)
Phenotypic Assessments
Hearing Evaluation
T3 study visit (~36 months)
Phenotypic Assessments
Interview on willingness for future study
T3 study visit (~36 months)
Phenotypic Assessments
DNA collection (DNA)
T3 study visit (~36 months)
Study Arms (5)
Children with Craniofacial Microsomia
125 children with craniofacial microsomia will be asked to come in for two study visits - when they are about 12 months old and again when they are about 36 months old. Procedures for children at the first visit include: assessment of development, video, photographs, and a hearing evaluation. Procedures for the final study visit include: assessment of development, photographs (2D \& 3D), video, saliva sample, hearing evaluation, speech assessment.
Children without Craniofacial Microsomia
Please note: we are not recruiting this group through ClinicalTrials.gov 100 children without craniofacial microsomia will be asked to come in for two study visits - when they are about 12 months old and again when they are about 36 months old. Procedures for the first visit include: assessment of development, video, and photographs. Procedures for the final study visit include: assessment of development, photographs (2D \& 3D), video, and speech assessment.
Parents of Children with Craniofacial Microsomia
125-250 parents of children with craniofacial microsomia will be asked to complete three visits - when their child is about 12 months old, 24 months old, and 36 months old. Parents will be asked to complete an interview at the first visit. The second visit consists of a telephone interview where parents will be asked about their child's hearing and health history. At the final study visit, parents will be asked to complete more questionnaires, have their picture taken, and donate saliva.
Parents of Children without Craniofacial Microsomia
Please note: we are not recruiting this group through ClinicalTrials.gov 100 parents of children without craniofacial microsomia will be asked to complete three visits - when their child is about 12 months old, 24 months old, and 36 months old. Parents will be asked to complete an interview at the first visit. The second visit consists of a telephone interview where parents will be asked about their child's hearing and health history. At the final study visit, parents will be asked to complete questionnaires and an interview.
Teacher/Day Care Provider
When the children participants are around 36 months old, we will ask parents for permission to contact their child's teacher/day care provider. We would like the teacher/day care provider to fill out a questionnaire.
Eligibility Criteria
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.
You may qualify if:
- Children with Craniofacial Microsomia:
- 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:
- 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
- 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.
- +5 more criteria
You may not qualify if:
- Children with Craniofacial Microsomia:
- 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
- Subject was born before 34 weeks estimated gestational age
- Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
- Sibling already participating in the CLOCK study
- Subject's consenting parent does not speak English or Spanish
- Parents of Children with Craniofacial Microsomia
- Anything that would preclude the subject's full compliance with or completion of the study.
- Subject does not speak English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seattle Children's Hospitallead
- National Institute of Dental and Craniofacial Research (NIDCR)collaborator
- Children's Hospital Los Angelescollaborator
- Children's Hospital of Philadelphiacollaborator
- University of North Carolinacollaborator
- Northwestern Universitycollaborator
- University of Illinois at Chicagocollaborator
- University of Washingtoncollaborator
- University of Pittsburghcollaborator
- New York Universitycollaborator
Study Sites (5)
Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
University of Illinois at Chicago
Chicago, Illinois, 60607, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 90027, United States
Seattle Children's Hospital
Seattle, Washington, 98101, United States
Biospecimen
Saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carrie L Heike, MD, MS
Seattle Children's Hospital
- PRINCIPAL INVESTIGATOR
Matthew L Speltz, PhD
Seattle Children's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2014
First Posted
August 25, 2014
Study Start
November 1, 2013
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
April 19, 2024
Record last verified: 2024-04