Timing of Primary Surgery for Cleft Palate - Full Text View

Purpose

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 specified technique, at age 6 months, when compared to surgery using the same technique age 12 months, improves speech development. All infants will be followed up at age 12 months, 3 years and five years for the assessment of the primary outcomes(age 5) and secondary outcomes.

Condition	Intervention
Cleft Palate	Procedure: primary surgery for cleft palate

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Baller-Gerold syndrome branchio-oculo-facial syndrome Crouzon syndrome

MedlinePlus related topics: Cleft Lip and Palate

U.S. FDA Resources

Further study details as provided by University of Manchester:

Primary Outcome Measures:

The primary outcome measure for the TOPS trial is insufficient velopharyngeal function age 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Insufficient velopharyngeal function at age 3 years; [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Velopharyngeal composite score summary at age 3 years and 5 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Canonical babbling at age 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Articulation at age 3 years and 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Perioperative complications; [ Time Frame: peri operative ] [ Designated as safety issue: Yes ]
Audiological assessment at 12 months, 3 years and 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Dentofacial development at 5 years. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Total intervention with speech and language pathologist [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Growth (Occipitofrontal circumference, crown heel length, weight) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	650
Study Start Date:	July 2010
Estimated Study Completion Date:	January 2019
Estimated Primary Completion Date:	January 2019 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 12 month surgery Infants will receive primary surgery at age 12 months using a standardized technique	Procedure: primary surgery for cleft palate Surgery completed using the Sommerlad technique
Experimental: 6 month surgery Infants will receive primary surgery at age 6 months using a standardized technique.	Procedure: primary surgery for cleft palate Surgery completed using the Sommerlad technique

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
OM8-30 questionnaires (completed by the parent)
Growth

Age 3 years

Speech development
Audiological assessments
OM8-30 questionnaire

Age 5 Years

Speech development
Audiological assessments
OM8-30 questionnaire
Dentofacial development (dental impressions and photographs)

Eligibility

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Infants with isolated cleft palate
Medically fit for operation at 6 months
Written informed proxy consent
One parent/carer a native language speaker in the country of residence

Exclusion Criteria:

Consent not obtained
A known associated syndrome 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993551

Contacts

Contact: William C Shaw, PhD	001 161 275 6661	bill.shaw@manchester.ac.uk
Contact: Nicola L Harman, PhD	001 151 282 4727	tops.trial@liverpool.ac.uk

Locations

Brazil
University of Sao Paulo	Recruiting
Bauru, Brazil
Contact: Inge Trindade
Principal Investigator: Inge Trindade
Denmark
Copenhagen Cleft Palate Centre	Recruiting
Copenhagen, Denmark
Contact: Line Dahl Jørgensen
Principal Investigator: Line Dahl Jørgensen
Århus Speech and Hearing Institute	Recruiting
Århus, Denmark
Principal Investigator: Louise Leturgie
Norway
Helse Bergen HF	Recruiting
Bergen, Norway
Principal Investigator: Hallvard Vindenes
Oslo University Hospital	Recruiting
Oslo, Norway
Principal Investigator: Michael Matzen
Sweden
Göteborg University	Recruiting
Göteborg, Sweden
Principal Investigator: Christina Persson
University of Linköping	Recruiting
Linköping, Sweden
Principal Investigator: Agneta Marcusson
Malmö University Hospital	Recruiting
Malmö, Sweden
Principal Investigator: Magnus Becker
Karolinska University Hospital	Recruiting
Stockholm, Sweden
Principal Investigator: Anette Lohmander
Umeå University	Recruiting
Umeå, Sweden
Principal Investigator: Karin Brunnegård
Uppsala University	Recruiting
Uppsala, Sweden
Principal Investigator: Malin Hakelius
United Kingdom
Belfast Health and Social Care Trust	Recruiting
Belfast, United Kingdom
Principal Investigator: Christine Hayden
Birmingham Children's NHS Foundation Trust	Recruiting
Birmingham, United Kingdom
Principal Investigator: Patricia Rorison
North Bristol NHS Foundation Trust	Recruiting
Bristol, United Kingdom
Principal Investigator: Liz Albery
Edinburgh Hospital for Sick Children	Recruiting
Edinburgh, United Kingdom
Principal Investigator: Felicity Mehendale
NHS Greater Glasgow and Clyde	Recruiting
Glasgow, United Kingdom
Principal Investigator: Mark Devlin
Leeds University Hospitals NHS foundation Trust	Recruiting
Leeds, United Kingdom
Principal Investigator: Alistair Smyth
Alder Hey Children's NHS Foundation Trust	Recruiting
Liverpool, United Kingdom, L12 2AP
Contact: Siobhan McMahon
Principal Investigator: Siobhan McMahon
Central Manchester University Hospitals NHS Foundation Trust	Recruiting
Manchester, United Kingdom
Principal Investigator: Bill Shaw
Newcastle University Hospitals NHs Foundation Trust	Recruiting
Newcastle, United Kingdom
Principal Investigator: Peter Hodgkinson
Abertawe Bro Morgannwg University Health Board	Recruiting
Swansea, United Kingdom
Principal Investigator: David Drake

Sponsors and Collaborators

University of Manchester

University of Liverpool

National Institute of Dental and Craniofacial Research (NIDCR)

More Information

No publications provided

Responsible Party:	University of Manchester - Dr Karen Shaw, University of Manchester
ClinicalTrials.gov Identifier:	NCT00993551 History of Changes
Other Study ID Numbers:	09-017-E, 1U01DE018837-01A1, Sponsor Reference: 57201, NIHR Portfolio Reference 30200
Study First Received:	October 9, 2009
Last Updated:	February 19, 2013
Health Authority:	United Kingdom: National Health Service

Keywords provided by University of Manchester:

cleft palate
paediatric
pediatric

surgery
speech
velopharyngeal

Additional relevant MeSH terms:

Cleft Palate
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities

Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 21, 2013

Timing of Primary Surgery for Cleft Palate (TOPS)