Cleft Lip and Palate Treatment Outcomes Study

Starting soon

Conditions studied: Cleft Lip and Palate

In brief

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.

Key facts

Study ID

NCT07687537

Run by

University of Florida

People needed

100

Starts

2026-08-01

Expected to finish

2029-07-31

Last updated by the study team

2026-07-07

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Other craniofacial syndromes requiring a substantially different management protocol
• Anticipated inability to complete any follow up
• Lack of parental consent

Full record on ClinicalTrials.gov

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