Timing of Primary Surgery for Cleft Palate (TOPS)

Kevin Munro

Status

Completed

Conditions

Cleft Palate

Treatments

Procedure: primary surgery for cleft palate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00993551

Sponsor Reference: 57201 (Other Identifier)

09-017-E

1U01DE018837-01A1 (U.S. NIH Grant/Contract)

NIHR Portfolio Reference 30200 (Other Identifier)

Details and patient eligibility

About

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 considered medically fit for operation at 6 months, and who meet the inclusion criteria, will be included in the trial and randomised to receive either:

Surgery at age 6 months, OR
Surgery at age 12 months.

The main objective is to determine whether surgery for cleft palate, using a Sommerlad technique, at age 6 months, when compared to surgery using the same technique at age 12 months, improves velopharyngeal function at age 5 years. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes( at age 5 years) and secondary outcomes.

Full 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
Growth

Age 3 years

Speech development
Audiological assessments

Age 5 Years

Speech development
Audiological assessments
Dentofacial development (Soft Tissue ANB and Maxillary arch constriction score using modified Huddart Bodenham scoring)

Enrollment

558 patients

Sex

All

Ages

Under 6 months old

Volunteers

No Healthy Volunteers

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.