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

NCT02224677 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 417

Last updated 2024-04-19

No results posted yet for this 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.

Conditions

  • Craniofacial Microsomia
  • Hemifacial Microsomia
  • Oculo-Auriculo-Vertebral-Syndrome
  • Goldenhar Syndrome
  • Microtia

Sponsors & Collaborators

Principal Investigators

  • Carrie L Heike, MD, MS · Seattle Children's Hospital

  • Matthew L Speltz, PhD · Seattle Children's Hospital

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2019-08-31
Completion
2019-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02224677 on ClinicalTrials.gov