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NCT07219901 · ClinicalTrials.gov registry record · NA
Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
A NA study, sponsored by Old Dominion University.
- Not yet
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT07219901: Clinical Trial NA study, sponsored by Old Dominion University.
NCT07219901 is a NA study that has not yet begun recruiting, run by Old Dominion University. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07219901, a NA study, has not yet begun recruiting, sponsored by Old Dominion University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
Number of words and concepts, as measured by the MacArthur-Bates Communicative Development Inventory (Words and Gestures)
Interventions
- BEHAVIORAL Early intervention for language, articulation and palatal function skills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-10-21 |
| Est. Completion | 2027-01-31 |
| Phase | NA |
What is known before NCT07219901 opens enrollment
NCT07219901 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Early intervention for language, articulation and palatal function skills is the first listed.
NCT07219901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07219901 about?
NCT07219901 is a clinical study titled "Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.". 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 mai...
What is the current status of trial NCT07219901?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2025-10-21. Estimated completion is 2027-01-31.
What interventions are being tested in trial NCT07219901?
The interventions under investigation include: Early intervention for language, articulation and palatal function skills (BEHAVIORAL).
Who is sponsoring clinical trial NCT07219901?
This trial is sponsored by Old Dominion University, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07219901's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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