Status:
RECRUITING
Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
University of Basel
Conditions:
Congenital Disorder
Cleft Lip Palate
Eligibility:
All Genders
1-6 years
Phase:
NA
Brief Summary
The goal of this observational study is to evaluate whether passive plate therapy using automated AI-designed devices can reduce cleft size in newborns with cleft lip and palate. The main questions it...
Detailed Description
This observational study investigates the impact of passive plate therapy using an automated, artificial intelligence (AI)-driven design workflow on presurgical cleft size in infants with unilateral c...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Infants diagnosed with unilateral cleft lip and palate Age at enrollment: within the first 14 days of life (for treatment group) Age at cleft surgery: approximately 4 months Medically stable and fit to undergo intraoral scanning and cleft surgery Parent or legal guardian has provided written informed consent
- Exclusion Criteria:
- Syndromic cleft lip and palate or other craniofacial syndromes Bilateral cleft lip and palate Significant comorbidities affecting feeding, growth, or surgery (e.g., cardiac anomalies) Premature infants (\<37 weeks gestational age at birth) Infants who have already undergone any presurgical orthopedic intervention elsewhere Guardians/ Parents unwilling or unable to comply with follow-up or study procedures
Exclusion
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06970158
Start Date
August 1 2023
End Date
December 31 2025
Last Update
May 16 2025
Active Locations (2)
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1
Saveetha Medical College
Chennai, India, 602105
2
GSR Hospital Hyderabad
Hyderabad, India, 500059