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

April 18, 2024 updated by: Carrie Heike, Seattle Children's Hospital
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
417

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • Illinois
      • Chicago, Illinois, United States, 60607
        • University of Illinois at Chicago
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 90027
        • Children's Hospital of Philadelphia
    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neurodevelopmental Outcome Measures
Time Frame: T1 study visit (12-14 months of age)
BSID-III Cognitive Index
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
2D photographs and video
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T2 study visit (~24 months)
Medical and Surgical History
T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
BSID-III Cognitive Index
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T1 study visit (12-14 months of age)
BSID-III Fine & Gross Motor
T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
Time Frame: T1 study visit (12-14 months of age)
PLS-V Auditory Comprehension
T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
Time Frame: T1 study visit (12-14 months of age)
PLS-V Expressive Language
T1 study visit (12-14 months of age)
Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
3D photographs,
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
Medical and Surgical History
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
Medical/dental chart abstraction
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
IT-MAIS: Auditory Assessment
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
OMENS rating from 2D images
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
Baby FACS observational protocol
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T1 study visit (12-14 months of age)
Clinical Hearing Test
T1 study visit (12-14 months of age)
Phenotypic Assessments
Time Frame: T2 study visit (~24 months)
IT-MAIS: Auditory Assessment
T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
BSID-III Fine & Gross Motor
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
Leiter-R Brief IQ
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
Leiter-R Forward Memory
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
Leiter-R Sustained Attention
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
Leiter-R Associated Pairs
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
Leiter-R Matching
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
Leiter-R Picture Context
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
PLS-V Auditory Comprehension
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
PLS-V Expressive Language
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
NEPSY-II Phonological Processing
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
ITSEA Parent
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
ITSEA Teacher
T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Time Frame: T3 study visit (~36 months)
Goldman-Fristoe Test of Articulation (GFTA-2)
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
2D photographs and video
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
3D photographs
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
Medical and Surgical History
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
Medical/dental chart abstraction
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
IT-MAIS: Auditory Assessment
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
OMENS rating from 2D images
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
Hearing Evaluation
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
Interview on willingness for future study
T3 study visit (~36 months)
Phenotypic Assessments
Time Frame: T3 study visit (~36 months)
DNA collection (DNA)
T3 study visit (~36 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seattle Children's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Philadelphia
Northwestern University
New York University
University of Pittsburgh
University of Illinois at Chicago
National Institute of Dental and Craniofacial Research (NIDCR)
University of Washington
Children's Hospital Los Angeles
University of North Carolina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carrie L Heike, MD, MS, Seattle Children's Hospital
  • Principal Investigator: Matthew L Speltz, PhD, Seattle Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIDCR: 13-002-E
  • R01DE022438-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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