Status:
UNKNOWN
An Investigation for the Optimal Timing of a Cleft Palate Repair
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cleft Palate
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
The effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. The objective of this study is to determine the effectiveness of early...
Detailed Description
The goals of palatoplasty are to provide an intact palate and to create a normally functioning velopharyngeal mechanism as early as possible without hazard to other aspects of health and development. ...
Eligibility Criteria
Inclusion
- Infant diagnosed with non-syndromic isolated unrepaired cleft involving the secondary palate.
- Between newborn and 5 months of age (pre-palate surgical assessment/ consultation.
- Treated at SickKids.
Exclusion
- If they are non-Ontario residents;
- If they have clinical features suggestive of an associated syndrome and/or an associated syndrome;
- If they have Pierre Robin sequence;
- If the palate repair cannot be performed before 15 months of age;
- If the extent of clefting is limited to the primary palate or submucous cleft of the soft palate;
- If the child have a combined cleft lip and palate diagnosis
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00779961
Start Date
April 1 2008
End Date
December 1 2023
Last Update
March 24 2022
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada