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NCT07687537
Cleft Lip and Palate Treatment Outcomes Study
Conditions: Cleft Lip and Palate
Sex: All
Ages: 1 Day – 12 Months
Healthy volunteers: No
Enrollment: 100
Sponsor: University of Florida
Summary
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
Inclusion Criteria
1. Diagnosis of cleft lip and or palate with clinical indication for presurgical infant orthopedic treatment
2. Age appropriate for presurgical infant orthopedic treatment, generally from birth until surgical repair
3. Parent or guardian ability to provide consent
4. Willingness to comply with follow up visits to the extent feasible given family circumstances
Exclusion Criteria
1. Other craniofacial syndromes requiring a substantially different management protocol
2. Anticipated inability to complete any follow up
3. Lack of parental consent
Source: ClinicalTrials.gov (NCT07687537). StuddyBuddy aggregates publicly available trial information.