Craniofacial MicrosomiaCLOCKNCT02224677
Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
An observational study of Craniofacial Microsomia and Hemifacial Microsomia, run by Seattle Children's Hospital at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 24 months
- Conditions the study is for
- Craniofacial Microsomia, Hemifacial Microsomia, Oculo-Auriculo-Vertebral-Syndrome
- How many people
- 417 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2013to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
Show all 20Show fewer
- 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.
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
University of Illinois at Chicago
Chicago, Illinois, 60607
Children's Hospital Los Angeles
Los Angeles, California, 90027
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 90027
Seattle Children's Hospital
Seattle, Washington, 98101
About this study
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.
- 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
- Medical subject headings
- Goldenhar Syndrome, Congenital Microtia, Facial Asymmetry, Coloboma, Macrostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental Outcome Measures
BSID-III Cognitive Index
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
2D photographs and video
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical and Surgical History
Measured: T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
BSID-III Cognitive Index
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
BSID-III Fine \& Gross Motor
Measured: T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
PLS-V Auditory Comprehension
Measured: T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
PLS-V Expressive Language
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
3D photographs,
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical and Surgical History
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical/dental chart abstraction
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
OMENS rating from 2D images
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
Baby FACS observational protocol
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
Clinical Hearing Test
Measured: T1 study visit (12-14 months of age)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
Measured: T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
BSID-III Fine \& Gross Motor
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Brief IQ
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Forward Memory
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Sustained Attention
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Associated Pairs
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Matching
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Picture Context
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
PLS-V Auditory Comprehension
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
PLS-V Expressive Language
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
NEPSY-II Phonological Processing
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
ITSEA Parent
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
ITSEA Teacher
Measured: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Goldman-Fristoe Test of Articulation (GFTA-2)
Measured: T3 study visit (~36 months)
Phenotypic Assessments
2D photographs and video
Measured: T3 study visit (~36 months)
Phenotypic Assessments
3D photographs
Measured: T3 study visit (~36 months)
Phenotypic Assessments
Medical and Surgical History
Measured: T3 study visit (~36 months)
Phenotypic Assessments
Medical/dental chart abstraction
Measured: T3 study visit (~36 months)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
Measured: T3 study visit (~36 months)
Phenotypic Assessments
OMENS rating from 2D images
Measured: T3 study visit (~36 months)
Phenotypic Assessments
Hearing Evaluation
Measured: T3 study visit (~36 months)
Phenotypic Assessments
Interview on willingness for future study
Measured: T3 study visit (~36 months)
Phenotypic Assessments
DNA collection (DNA)
Measured: T3 study visit (~36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2014 (estimated)
- Study startNov 2013
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial MicrosomiaStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Children's Hospital Los Angeles, Children's Hospital of Philadelphia, University of North Carolina, Northwestern University, University of Illinois Chicago, University of Washington, University of Pittsburgh, New York University
- Responsible party
- Principal investigator, Carrie Heike, Seattle Children's Hospital
- Investigators
- Carrie L Heike, MD, MS, Principal investigator, Seattle Children's HospitalMatthew L Speltz, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02224677
- Sponsor's protocol ID
- NIDCR: 13-002-E
- Other IDs
- R01DE022438-01
- Acronym
- CLOCK
- Status last verified
- Apr 2024
- First submitted
- 19 Aug 2014
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
- ClinicalTrials.gov ID
- NCT02224677
- Acronym / sponsor ID
- CLOCK / NIDCR: 13-002-E
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), Children's Hospital Los Angeles, Children's Hospital of Philadelphia, University of North Carolina, Northwestern University, University of Illinois Chicago, University of Washington, University of Pittsburgh, New York University
- Study start
- Nov 2013 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 25 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurodevelopmental Outcome Measures
Time frame: T1 study visit (12-14 months of age)
BSID-III Cognitive Index
Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
2D photographs and video
Phenotypic Assessments
Time frame: T2 study visit (~24 months)
Medical and Surgical History
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
BSID-III Cognitive Index
Neurodevelopmental Outcome Measures
Time frame: T1 study visit (12-14 months of age)
BSID-III Fine \& Gross Motor
Neurodevelopmental Outcome Measures
Time frame: T1 study visit (12-14 months of age)
PLS-V Auditory Comprehension
Neurodevelopmental Outcome Measures
Time frame: T1 study visit (12-14 months of age)
PLS-V Expressive Language
Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
3D photographs,
Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
Medical and Surgical History
Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
Medical/dental chart abstraction
Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
IT-MAIS: Auditory Assessment
Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
OMENS rating from 2D images
Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
Baby FACS observational protocol
Phenotypic Assessments
Time frame: T1 study visit (12-14 months of age)
Clinical Hearing Test
Phenotypic Assessments
Time frame: T2 study visit (~24 months)
IT-MAIS: Auditory Assessment
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
BSID-III Fine \& Gross Motor
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
Leiter-R Brief IQ
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
Leiter-R Forward Memory
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
Leiter-R Sustained Attention
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
Leiter-R Associated Pairs
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
Leiter-R Matching
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
Leiter-R Picture Context
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
PLS-V Auditory Comprehension
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
PLS-V Expressive Language
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
NEPSY-II Phonological Processing
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
ITSEA Parent
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
ITSEA Teacher
Neurodevelopmental Outcome Measures
Time frame: T3 study visit (~36 months)
Goldman-Fristoe Test of Articulation (GFTA-2)
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
2D photographs and video
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
3D photographs
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
Medical and Surgical History
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
Medical/dental chart abstraction
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
IT-MAIS: Auditory Assessment
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
OMENS rating from 2D images
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
Hearing Evaluation
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
Interview on willingness for future study
Phenotypic Assessments
Time frame: T3 study visit (~36 months)
DNA collection (DNA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie L Heike, MD, MS principal investigator
Seattle Children's Hospital
Matthew L Speltz, PhD principal investigator
Seattle Children's Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniofacial Microsomia and Hemifacial Microsomia, run by Seattle Children's Hospital at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental Outcome Measures (time frame: T1 study visit (12-14 months of age)). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.