Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:51 PM
Ignite Modification Date:
2025-12-24 @ 12:51 PM
NCT ID:
NCT00779961
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
5 Months
Study:
NCT00779961
Study Brief:
Protocol Section:
NCT00779961