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Cleft Palate Repair for Cleft Palate
N/A
Waitlist Available
Led By David M Fisher, MD, FRCSC
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years of age, 11-13 years of age
Awards & highlights
Study Summary
This trial is testing whether earlier repair of cleft palate leads to better speech development, velopharyngeal functioning, and facial growth outcomes, compared to the Hospital for Sick Children's routine repair.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years of age, 11-13 years of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years of age, 11-13 years of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age.
Secondary outcome measures
Cephalometry
Operative Surgical Procedures
Surgical Complications: Surgical complications (i.e. fistula and dehiscence) will be evaluated between 6-8 weeks post-operatively and recorded.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group AExperimental Treatment1 Intervention
Early Cleft Palate Repair (Age group 6-10 months)
Group II: Group BActive Control1 Intervention
Sick Kids Routine cleft palate repair (age group 10-14 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palatoplasty
2019
N/A
~20
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,473 Total Patients Enrolled
David M Fisher, MD, FRCSCPrincipal InvestigatorThe Hospital for Sick Children, Toronto, Canada
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You were born with a condition called Pierre Robin sequence.The baby has a gap in the roof of their mouth that has not been repaired and is not related to any other medical condition.If your cleft lip and/or palate only affects the front portion of your mouth or the roof of your mouth.The child has both a cleft lip and palate.You have symptoms or a medical condition that suggest you may have a related syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Group A
- Group 2: Group B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions left for participants in this clinical trial?
"This study is no longer recruiting participants, according to the clinicaltrials.gov website. The trial was originally posted on 4/1/2008, and the most recent update was on 3/23/2022. There are 12 other similar trials enrolling patients at this time."
Answered by AI
Can people who are younger than 50 years old join this clinical trial?
"According to the information available, the age limit for this trial is 5 months old. If the patient is a minor, then there are 12 different trials they could be eligible for. If the patient is over 65, then there are 2 trials they could be eligible for."
Answered by AI
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