Status:
COMPLETED
Timing of Primary Surgery for Cleft Palate
Lead Sponsor:
Kevin Munro
Collaborating Sponsors:
University of Liverpool
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Cleft Palate
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
This trial is a randomised controlled trial with a parallel design taking place in centres across the UK, Scandinavia and Brazil. 650 infants with a diagnosis of isolated cleft palate who are conside...
Detailed Description
Infants will be followed up at age 12 months, 3 years and five years. At each visit the following will be assessed: Age 12 months * Speech development (canonical babbling) * Audiological assessments...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2021
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT00993551
Start Date
July 1 2010
End Date
March 26 2021
Last Update
August 13 2021
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Sao Paulo
Bauru, Brazil
2
Århus Speech and Hearing Institute
Aarhus, Denmark
3
Copenhagen Cleft Palate Centre
Copenhagen, Denmark
4
Helse Bergen HF
Bergen, Norway