CompletedNot Applicable

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

United States417 participantsStarted 2013-11

Plain-language 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.

Who can participate

Age range

12 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neurodevelopmental Outcome Measures

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

Phenotypic Assessments

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

Phenotypic Assessments

Timeframe: T2 study visit (~24 months)

Neurodevelopmental Outcome Measures

Timeframe: T3 study visit (~36 months)

Neurodevelopmental Outcome Measures

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

Neurodevelopmental Outcome Measures

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

Neurodevelopmental Outcome Measures

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

Trial details

NCT IDNCT02224677

SponsorSeattle Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08-31

View on ClinicalTrials.gov More Craniofacial Microsomia trials

Plain-language summary

Who can participate

Age range

12 Months – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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.

Exclusion criteria

What they're measuring

Neurodevelopmental Outcome Measures

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

Phenotypic Assessments

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

Phenotypic Assessments

Timeframe: T2 study visit (~24 months)

Neurodevelopmental Outcome Measures

Timeframe: T3 study visit (~36 months)

Neurodevelopmental Outcome Measures

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

Neurodevelopmental Outcome Measures

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

Neurodevelopmental Outcome Measures

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