Craniofacial Microsomia: Longitudinal Outcomes in Children Pre-Kindergarten (CLOCK)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 417
- 试验地点
- 5
- 主要终点
- Phenotypic Assessments
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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.
排除标准
- •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
结局指标
主要结局
Phenotypic Assessments
时间窗: T3 study visit (~36 months)
DNA collection (DNA)
Phenotypic Assessments Phenotypic Assessments Phenotypic Assessments
时间窗: T1 study visit (12-14 months of age)
3D photographs,
Neurodevelopmental Outcome Measures
时间窗: T3 study visit (~36 months)
Goldman-Fristoe Test of Articulation (GFTA-2)
次要结局
未报告次要终点
研究者
Carrie Heike
Principal Investigator
Seattle Children's Hospital