biostudies-literatureLuquetti DVNIDCR NIH HHSNCATS NIH HHSNational Institute of Dental and Craniofacial Research877-889https://www.ebi.ac.uk/biostudies/studies/S-EPMC6996714biostudies-literatureUnknown56(7)<h4>Objective</h4>The Craniofacial microsomia: Longitudinal Outcomes in Children pre-Kindergarten (CLOCK) study is a longitudinal cohort study of neurobehavioral outcomes in infants and toddlers with craniofacial microsomia (CFM). In this article, we review the data collection and methods used to characterize this complex condition and describe the demographic and clinical characteristics of the cohort.<h4>Setting</h4>Craniofacial and otolaryngology clinics at 5 study sites.<h4>Participants</h4>Infants with CFM and unaffected infants (controls) ages 12 to 24 months were recruited from the same geographical regions and followed to age 36 to 48 months.<h4>Methods</h4>Phenotypic, neurodevelopmental, and facial expression assessments were completed during the first and third waves of data collThe Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial AssociationMethods and Challenges in a Cohort Study of Infants and Toddlers With Craniofacial Microsomia: The Clock Study.PMC6996714R01 DE022438R01 DE 022438UL1 TR000423UL1 TR002319Collett BRKinter SLJohns ALHeike CLLuquetti DVLeroux BGDrake AFSie KSpeltz MLNorton SSiebold BWallace ERKapp-Simon KAMagee LfalseMethods and Challenges in a Cohort Study of Infants and Toddlers With Craniofacial Microsomia: The Clock Study.<h4>Objective</h4>The Craniofacial microsomia: Longitudinal Outcomes in Children pre-Kindergarten (CLOCK) study is a longitudinal cohort study of neurobehavioral outcomes in infants and toddlers with craniofacial microsomia (CFM). In this article, we review the data collection and methods used to characterize this complex condition and describe the demographic and clinical characteristics of the cohort.<h4>Setting</h4>Craniofacial and otolaryngology clinics at 5 study sites.<h4>Participants</h4>Infants with CFM and unaffected infants (controls) ages 12 to 24 months were recruited from the same geographical regions and followed to age 36 to 48 months.<h4>Methods</h4>Phenotypic, neurodevelopmental, and facial expression assessments were completed during the first and third waves of data coll2019-01-01T00:00:00Z2019 Aug2025-04-19T04:29:51.883Z2020-09-11T07:23:44ZS-EPMC69967143062144510.1177/1055665618821014