Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
NCT ID: NCT02224677
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
417 participants
OBSERVATIONAL
2013-11-30
2019-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neurodevelopmental Outcomes in Craniosynostosis Repair
NCT04072783
Examination of Neuromotor Development of Cases Diagnosed with Scaphocephaly
NCT06294626
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
NCT05917678
Neurodevelopment in Infants With Complex Congenital Heart Defects
NCT03104751
Use of AEEG as Predictor of Long-term Motor Outcome in Neonates With Congenital Heart Disease
NCT01291797
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
12 Months
24 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Dental and Craniofacial Research (NIDCR)
NIH
Children's Hospital Los Angeles
OTHER
Children's Hospital of Philadelphia
OTHER
University of North Carolina
OTHER
Northwestern University
OTHER
University of Illinois at Chicago
OTHER
University of Washington
OTHER
University of Pittsburgh
OTHER
New York University
OTHER
Seattle Children's Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carrie Heike
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carrie L Heike, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Matthew L Speltz, PhD
Role: PRINCIPAL_INVESTIGATOR
Seattle Children's Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's Hospital Los Angeles
Los Angeles, California, United States
University of Illinois at Chicago
Chicago, Illinois, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIDCR: 13-002-E
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.