Status:
NOT_YET_RECRUITING
Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
Lead Sponsor:
Old Dominion University
Collaborating Sponsors:
Childrens Hospital of the King's Daughters
Conditions:
Cleft Lip and Cleft Palate
Cleft Lip Palate
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if teaching speech skills to infants with cleft palates, prior to palate repair, will help them to develop speech and language skills. It will also learn ab...
Detailed Description
Participants Participants will be caregiver-infant dyads, where the infant is aged between six and twelve months at the time of study enrolment. Infants should be under the current care of a craniofa...
Eligibility Criteria
Inclusion
- Infants with unrepaired cleft palate (with or without cleft lip)
- Aged between 6 and 10 months at the time of study commencement
Exclusion
- Medically fragile status that would preclude participation in this community-based study.
- Palatoplasty completed.
- Aged over one year
- Infants with cleft lip only
Key Trial Info
Start Date :
October 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07219901
Start Date
October 21 2025
End Date
January 31 2027
Last Update
October 22 2025
Active Locations (1)
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1
Old Dominion University
Norfolk, Virginia, United States, 23529