Timing of Primary Surgery for Cleft Palate (TOPS)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2015 by University of Manchester
Sponsor:
NHarman
Collaborators:
University of Liverpool
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
NHarman, University of Manchester
ClinicalTrials.gov Identifier:
NCT00993551
First received: October 9, 2009
Last updated: May 26, 2015
Last verified: May 2015
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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: | June 2020 |
| Estimated Primary Completion Date: | June 2020 (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 (Child) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993551
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
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
| Principal Investigator: | William C Shaw | University of Manchester |
More Information
| 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: | May 26, 2015 |
| 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 September 28, 2016