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NCT02224677 · ClinicalTrials.gov registry record
Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
A clinical trial of Microtia and Craniofacial Microsomia, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- 417
- Enrollment target
- 5
- Study locations
NCT02224677: Completed study of Microtia and Craniofacial Microsomia, sponsored by Seattle Children's Hospital.
NCT02224677 is a study of Microtia and Craniofacial Microsomia that has completed, run by Seattle Children's Hospital. The registered enrollment target is 417 participants, below the 1,529-participant average among 4 other Microtia trials with a reported enrollment target (73% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02224677, a study of Microtia and Craniofacial Microsomia, has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- 417 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
BSID-III Cognitive Index
Conditions Studied
Study Locations (5)
California
- Children's Hospital Los Angeles - Los Angeles
Illinois
- University of Illinois at Chicago - Chicago
North Carolina
- University of North Carolina - Chapel Hill
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 417 participants |
| Start Date | 2013-11 |
| Est. Completion | 2019-08-31 |
What the finished NCT02224677 record still lists
NCT02224677 is an observational study that tracks outcomes without assigning an intervention. The registered 417 participants enrollment target is mid-sized for trials with a published cap, below the 1,529-participant average among 4 other Microtia trials with a reported enrollment target (73% lower).
The record links to 5 conditions, with Microtia appearing as the primary indexed condition, and to 0 interventions.
NCT02224677 lists 5 locations in 5 states (California, Illinois, North Carolina).
Frequently Asked Questions
What is clinical trial NCT02224677 about?
NCT02224677 is a clinical study titled "Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)". 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 tod...
What is the current status of trial NCT02224677?
This trial is currently completed. The enrollment target is 417 participants. The study started on 2013-11. Estimated completion is 2019-08-31.
What conditions does trial NCT02224677 study?
This clinical trial studies the following conditions: Microtia, Craniofacial Microsomia, Hemifacial Microsomia, Goldenhar Syndrome, Oculo-Auriculo-Vertebral-Syndrome.
Who is sponsoring clinical trial NCT02224677?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02224677 being conducted?
This trial has 5 study locations across California, Illinois, North Carolina, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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