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 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT00993551
Eligibility Criteria:
Inclusion Criteria:
* Infants with isolated cleft palate
* Medically fit for operation at 6 months, corrected for gestational age
* Written informed proxy consent
* One parent/carer a native language speaker in the country of residence
Exclusion Criteria:
* Consent not obtained
* b. Infants with syndromic cleft palate (except Van der Woude syndrome, which can be included if hearing is not affected) or severe developmental delay
* Congenital sensorineural hearing loss or middle ear anomalies;
* Variation in the anatomical presentation is such that the surgeon who will perform the procedure considers that one stage closure with the Sommerlad technique would be inappropriate;
* Submucous cleft palate (defined by the classical triad of signs, bifid, uvula, bony defect of the hard palate, muscular diastasis, as described by Jensen et al (1988).
* Where the language spoken at home is not the majority language in the country of residence.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Months
Study:
NCT00993551
Study Brief:
Protocol Section:
NCT00993551