Actively Recruiting
Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate
Led by University Hospital, Basel, Switzerland · Updated on 2025-05-16
70
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
U
University of Basel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 aims to answer are: Does AI-designed passive plate therapy reduce the cleft size between birth and primary surgery? (Primary aim) How does cleft size at the time of surgery compare between infants who received passive plate therapy and those who did not? (Secondary aim) Researchers will compare infants who received AI-designed passive plate therapy with those who received no presurgical therapy to determine whether the intervention leads to a greater reduction in cleft width. Participants will: Undergo intraoral scans at birth and again at the time of primary surgery, around 4 months of age. Receive either no presurgical intervention or be treated with AI-designed passive plates, depending on site-specific clinical practices
CONDITIONS
Official Title
Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Saveetha Medical College
Chennai, India, 602105
Actively Recruiting
2
GSR Hospital Hyderabad
Hyderabad, India, 500059
Actively Recruiting
Research Team
P
Prasad Nalabothu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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