Cleft Lip and Palate Treatment Outcomes Study
ConditionCleft Lip and Palate
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-12
SponsorUniversity of Florida
About this trial
Infants with cleft lip and palate often benefit from presurgical infant orthopedic treatment before surgical repair. Multiple standard of care approaches are selected based on each infant's clinical presentation and family circumstances. This prospective observational cohort study will evaluate clinical outcomes, treatment efficiency, and family burden using routinely collected clinical records and photographs to support individualized, evidence-based PSIO treatment planning.
Eligibility criteria
Qualifiers
Diagnosis of cleft lip and or palate with clinical indication for presurgical infant orthopedic treatment
Age appropriate for presurgical infant orthopedic treatment, generally from birth until surgical repair
Parent or guardian ability to provide consent
Willingness to comply with follow up visits to the extent feasible given family circumstances
Disqualifiers
Other craniofacial syndromes requiring a substantially different management protocol
Anticipated inability to complete any follow up
Lack of parental consent
Trial design
Treatments tested in this trial
- Not listed
Trial groups
100 Participants
are grouped into 1 trial groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov