Early Intervention for Cleft Palate
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether teaching speech skills to infants with cleft palates before surgery aids in developing better speech and language abilities. Researchers aim to determine if techniques, typically used for late-talking children, can help these infants produce more sounds and learn new words more quickly. Families with infants aged 6 to 10 months who have an unrepaired cleft palate (a gap in the roof of the mouth) and not just a cleft lip are eligible to participate. As an unphased trial, this study offers families the chance to contribute to research that could improve early speech development strategies for infants with cleft palates.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these early intervention techniques are safe for infants with cleft palates?
Research has shown that early speech treatments for children with a cleft palate are generally safe. Specifically, surgery to repair the cleft before 18 months of age is linked to better speech and social skills, regardless of the cleft's severity. Although this study focused on surgery, the positive results suggest that starting treatment early can be beneficial and is usually well-tolerated.
Another study found that certain speech techniques, such as the Principles of Motor Learning (PML), successfully improved speech in children with a cleft palate. While this study was in the early stages, it did not identify any major safety issues.
Overall, these treatments appear safe and could help improve speech skills in children with a cleft palate.12345Why are researchers excited about this trial?
Researchers are excited about this early intervention for cleft palate because it focuses on enhancing language, articulation, and palatal function skills right from the start. Unlike traditional treatments that often begin after the child has developed speech difficulties, this approach targets the issue proactively, potentially preventing problems before they arise. The method emphasizes early and consistent intervention, which could lead to better long-term outcomes for speech and communication skills in affected children. By addressing these skills early, the intervention aims to significantly improve quality of life and reduce the need for more extensive therapies later on.
What evidence suggests that early intervention techniques are effective for infants with cleft palates?
Research has shown that starting treatment early can greatly improve speech and language skills in babies with cleft palates. In this trial, all participants will receive early intervention focused on language, articulation, and palatal function skills. Studies have found that customized speech therapy can lead to better communication and fewer speech problems later on. For instance, early treatment helps babies learn more words and make important sounds like "b" and "p". A review of research found that personalized speech therapy effectively prevents long-term issues with talking, reading, and social skills in children with cleft conditions. Overall, early treatment appears to be a promising way to help children with cleft palates develop better speech and language skills.678910
Who Is on the Research Team?
Victoria Reynolds, LLB BSc PhD
Principal Investigator
Old Dominion University
Are You a Good Fit for This Trial?
This trial is for infants with unrepaired cleft palates. It's designed to see if early speech skills teaching helps language development before palate repair surgery. Infants will be evaluated and attend clinic visits twice a week for six weeks in a group setting.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Evaluation
Participants undergo a baseline evaluation of speech and language skills
Treatment
Participants attend twice-weekly sessions for six weeks to learn techniques to help infants develop speech and language skills
Final Evaluation
Participants undergo a final evaluation of speech and language skills
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Early Intervention for Language, Articulation, and Palatal Function Skills
Find a Clinic Near You
Who Is Running the Clinical Trial?
Old Dominion University
Lead Sponsor
Childrens Hospital of the King's Daughters
Collaborator