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Completed

NCT Number: NCT02224677

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 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.

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Key information

Conditions

Craniofacial Microsomia Bone Diseases Bone Diseases, Developmental Coloboma Congenital Abnormalities Congenital Microtia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniofacial Dysostosis Dysostoses Ear Diseases Eye Abnormalities Eye Diseases Eye Diseases, Hereditary Facial Asymmetry Goldenhar Syndrome Hemifacial Microsomia Macrostomia Mandibulofacial Dysostosis Microtia Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Oculo-Auriculo-Vertebral-Syndrome Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

12 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

We are currently looking to enroll children with craniofacial microsomia through ClinicalTrials.gov

Inclusion criteria

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)
  • 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.

Exclusion criteria

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.
  • 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

Treatment and study plan

Primary outcomes

  1. Neurodevelopmental Outcome Measures

    Time frame: T1 study visit (12-14 months of age)

    BSID-III Cognitive Index

  2. Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    2D photographs and video

  3. Phenotypic Assessments

    Time frame: T2 study visit (~24 months)

    Medical and Surgical History

  4. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    BSID-III Cognitive Index

  5. Neurodevelopmental Outcome Measures

    Time frame: T1 study visit (12-14 months of age)

    BSID-III Fine & Gross Motor

  6. Neurodevelopmental Outcome Measures

    Time frame: T1 study visit (12-14 months of age)

    PLS-V Auditory Comprehension

  7. Neurodevelopmental Outcome Measures

    Time frame: T1 study visit (12-14 months of age)

    PLS-V Expressive Language

  8. Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    3D photographs,

  9. Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    Medical and Surgical History

  10. Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    Medical/dental chart abstraction

  11. Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    IT-MAIS: Auditory Assessment

  12. Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    OMENS rating from 2D images

  13. Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    Baby FACS observational protocol

  14. Phenotypic Assessments

    Time frame: T1 study visit (12-14 months of age)

    Clinical Hearing Test

  15. Phenotypic Assessments

    Time frame: T2 study visit (~24 months)

    IT-MAIS: Auditory Assessment

  16. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    BSID-III Fine & Gross Motor

  17. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    Leiter-R Brief IQ

  18. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    Leiter-R Forward Memory

  19. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    Leiter-R Sustained Attention

  20. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    Leiter-R Associated Pairs

  21. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    Leiter-R Matching

  22. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    Leiter-R Picture Context

  23. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    PLS-V Auditory Comprehension

  24. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    PLS-V Expressive Language

  25. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    NEPSY-II Phonological Processing

  26. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    ITSEA Parent

  27. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    ITSEA Teacher

  28. Neurodevelopmental Outcome Measures

    Time frame: T3 study visit (~36 months)

    Goldman-Fristoe Test of Articulation (GFTA-2)

  29. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    2D photographs and video

  30. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    3D photographs

  31. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    Medical and Surgical History

  32. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    Medical/dental chart abstraction

  33. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    IT-MAIS: Auditory Assessment

  34. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    OMENS rating from 2D images

  35. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    Hearing Evaluation

  36. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    Interview on willingness for future study

  37. Phenotypic Assessments

    Time frame: T3 study visit (~36 months)

    DNA collection (DNA)

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Children's Hospital Los Angeles
  • Children's Hospital of Philadelphia
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • New York University
  • Northwestern University
  • University of Illinois at Chicago
  • University of North Carolina
  • University of Pittsburgh
  • University of Washington

Registry information

Acronym: CLOCK

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 25, 2014
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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