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 Type
OBSERVATIONAL
Enrollment
417
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
Neurodevelopmental Outcome Measures
BSID-III Cognitive Index
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
2D photographs and video
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical and Surgical History
Time frame: T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
BSID-III Cognitive Index
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
BSID-III Fine \& Gross Motor
Time frame: T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
PLS-V Auditory Comprehension
Time frame: T1 study visit (12-14 months of age)
Neurodevelopmental Outcome Measures
PLS-V Expressive Language
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
3D photographs,
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical and Surgical History
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
Medical/dental chart abstraction
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
OMENS rating from 2D images
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
Baby FACS observational protocol
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
Clinical Hearing Test
Time frame: T1 study visit (12-14 months of age)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
Time frame: T2 study visit (~24 months)
Neurodevelopmental Outcome Measures
BSID-III Fine \& Gross Motor
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Brief IQ
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Forward Memory
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Sustained Attention
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Associated Pairs
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Matching
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Leiter-R Picture Context
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
PLS-V Auditory Comprehension
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
PLS-V Expressive Language
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
NEPSY-II Phonological Processing
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
ITSEA Parent
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
ITSEA Teacher
Time frame: T3 study visit (~36 months)
Neurodevelopmental Outcome Measures
Goldman-Fristoe Test of Articulation (GFTA-2)
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
2D photographs and video
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
3D photographs
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
Medical and Surgical History
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
Medical/dental chart abstraction
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
IT-MAIS: Auditory Assessment
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
OMENS rating from 2D images
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
Hearing Evaluation
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
Interview on willingness for future study
Time frame: T3 study visit (~36 months)
Phenotypic Assessments
DNA collection (DNA)
Time frame: T3 study visit (~36 months)
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