Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
Starting soon · Not applicable
Conditions studied: Cleft Lip and Cleft Palate, Cleft Lip Palate, Cleft Lip and/or Palate, Cleft Palate, Cleft Palate Children, Cleft Palates, Cleft Palate Repair
In brief
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.
Key facts
- Study ID
- NCT07219901
- Run by
- Old Dominion University
- People needed
- 200
- Starts
- 2025-10-21
- Expected to finish
- 2027-01-31
- Last updated by the study team
- 2025-10-22
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants with unrepaired cleft palate (with or without cleft lip)
- Aged between 6 and 10 months at the time of study commencement
You may not qualify if…
- Medically fragile status that would preclude participation in this community-based study.
- Palatoplasty completed.
- Aged over one year
- Infants with cleft lip only
Where it is running
- Old Dominion University — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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