Clinical Trial

Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.

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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 about whether the skills are linked to fewer speech sound difficulties when they start school. The main questions it aims to answer are: Do standard, early intervention techniques to promote language development, that are used in children who are late talkers, work in infants with cleft palates? Will infants with cleft palates increase the number of sounds they use after targeted intervention? Can infants attempt to make stop sounds, like b and p, after targeted intervention? Can infants with cleft palate learn new words more quickly when they are used with gestures? Participants will: Participate in a baseline evaluation of speech and language skills, either in person, or via Telehealth. Attend the clinic for twice-weekly visits, for six weeks, to learn techniques to help their infants develop their speech and language skills, in a group setting with other families of infants with cleft palate. Participate in a final evaluation of speech and language skills, either in person, or via Telehealth.
Trial Details
NCT Number NCT07219901
Lead Sponsor Old Dominion University
Collaborators: Children's Hospital of The King's Daughters
Conditions Cleft Lip and Cleft Palate, Cleft Lip Palate, Cleft Lip and/or Palate, Cleft Palate, Cleft Palate Children, Cleft Palates, Cleft Palate Repair
Enrollment 200 participants
Start Date 2025-10-21
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-22