Timing of Primary Surgery for Cleft Palate (TOPS)

This study is currently recruiting participants.
Verified August 2013 by University of Manchester
Sponsor:
Collaborators:
University of Liverpool
Information provided by (Responsible Party):
NHarman, University of Manchester
ClinicalTrials.gov Identifier:
NCT00993551
First received: October 9, 2009
Last updated: August 15, 2013
Last verified: August 2013
  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
Official Title: Timing of Primary Surgery for Cleft Palate

Resource links provided by NLM:


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
  • Growth

Age 3 years

  • Speech development
  • Audiological assessments

Age 5 Years

  • Speech development
  • Audiological assessments
  • 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         
Oxford University Hospitals NHS Trust Recruiting
Oxford, United Kingdom
Contact: Stephen Robinson         
Principal Investigator: Stephen Robinson         
Salisbury District Hospital Recruiting
Salisbury, United Kingdom
Contact: Stephen Robinson         
Principal Investigator: Stephen Robinson         
Abertawe Bro Morgannwg University Health Board Recruiting
Swansea, United Kingdom
Principal Investigator: David Drake         
Sponsors and Collaborators
NHarman
University of Liverpool
Investigators
Principal Investigator: William C Shaw University of Manchester
  More Information

No publications provided

Responsible Party: NHarman, Dr. Nicola Harman, Senior Trials Manager, 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: August 15, 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:
Jaw Diseases
Cleft Palate
Jaw Abnormalities
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 April 17, 2014