Timing of Primary Surgery for Cleft Palate (TOPS)

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ClinicalTrials.gov Identifier: NCT00993551

Recruitment Status : Active, not recruiting

First Posted : October 12, 2009

Last Update Posted : November 20, 2017

Sponsor:

Collaborators:

University of Liverpool

National Institute of Dental and Craniofacial Research (NIDCR)

Information provided by (Responsible Party):

William Shaw, University of Manchester

Study Description

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 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 or disease	Intervention/treatment	Phase
Cleft Palate	Procedure: primary surgery for cleft palate	Not Applicable

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)

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	558 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Timing of Primary Surgery for Cleft Palate
Study Start Date :	July 2010
Estimated Primary Completion Date :	August 2020
Estimated Study Completion Date :	September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cleft Lip and Palate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

The primary outcome measure for the TOPS trial is insufficient velopharyngeal function. [ Time Frame: 5 years ]
Unit of measure: Sufficient (VPC sum <=3) or insufficient (VPC sum>=4). VPC sum measured on scale from 1 to 6.

Secondary Outcome Measures :

Insufficient velopharyngeal function [ Time Frame: 3 years ]
unit of measure to be confirmed. It will be measured by either "yes" or "no" or a 3 point scale; insufficient, marginal or sufficient
Canonical babbling measured by canonical babbling present [ Time Frame: 12 months ]
unit of measure: Yes or No c. Oral consonant errors
Canonical babbling measured by canonical babbling ratio [ Time Frame: 12 months ]
unit of measure: % of canonical babbling
Canonical babbling measured by consonant inventory [ Time Frame: 12 months ]
unit of measure: number of correct sounds produced
Articulation [ Time Frame: 3 years ]
unit of measure: % consonant correct (PCC)
Articulation [ Time Frame: 3 years ]
unit of measure: % correct placement (PCP)
Articulation [ Time Frame: 3 years ]
unit of measure: % correct manner (PCM)
Articulation [ Time Frame: 3 years ]
unit of measure: % of children with non-oral consonant errors
Articulation [ Time Frame: 5 years ]
unit of measure: % consonants correct (PCC)
Articulation [ Time Frame: 5 years ]
unit of measure: % of children with non-oral consonant errors
Articulation [ Time Frame: 5 years ]
unit of measure: % of children with oral consonant errors
Postoperative/long term complications measured by dehiscence [ Time Frame: up to 48 hours post operation ]
unit of measure: yes or no for dehiscence present
Postoperative/long term complications measured by dehiscence [ Time Frame: up to 30 days post operation ]
unit of measure: yes or no for dehiscence present
Postoperative/long term complications measured by infection [ Time Frame: up to 48 hours post operation ]
unit of measure: yes or no for infection present
Postoperative/long term complications measured by infection [ Time Frame: up to 30 days post operation ]
unit of measure: yes or no for infection present
Postoperative/long term complications measured by evidence of fistula [ Time Frame: up to 30 days post operation ]
unit of measure: yes or no for fistula present
Postoperative/long term complications measured by evidence of fistula [ Time Frame: 3 years ]
unit of measure: yes or no for fistula present
Postoperative/long term complications measured by evidence of fistula [ Time Frame: 5 years ]
unit of measure: yes or no for fistula present
Hearing level [ Time Frame: 12 months ]
unit of measure: yes or no by Abnormal Transient Otoacoustic Emission (TEOAE)
Hearing level [ Time Frame: 12 months ]
unit of measure: yes or no by Abnormal Soundfield audiometry
Hearing level [ Time Frame: 3 years ]
unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear
Hearing level [ Time Frame: 3 years ]
unit of measure: yes or no by Abnormal Puretone audiometry in both ears
Hearing level [ Time Frame: 3 years ]
unit of measure: Severity of better ear categorised as normal, mild, moderate or severe
Hearing level [ Time Frame: 5 years ]
unit of measure: yes or no by Abnormal Puretone audiometry in at least one ear
Hearing level [ Time Frame: 5 years ]
unit of measure: yes or no by Abnormal Puretone audiometry in both ears
Hearing level [ Time Frame: 5 years ]
unit of measure: Severity of better ear categorised as normal, mild, moderate, severe or profound
Middle ear function [ Time Frame: 12 months ]
unit of measure: yes or no by flat line Tympanogram in at least one ear
Middle ear function [ Time Frame: 3 years ]
unit of measure: yes or no by flat line Tympanogram in at least one ear
Middle ear function [ Time Frame: 5 years ]
unit of measure: yes or no by flat line Tympanogram in at least one ear
Middle ear function [ Time Frame: 12 months ]
unit of measure: yes or no by flat line Tympanogram in both ears
Middle ear function [ Time Frame: 3 years ]
unit of measure: yes or no by flat line Tympanogram in both ears
Middle ear function [ Time Frame: 5 years ]
unit of measure: yes or no by flat line Tympanogram in both ears
Dentofacial development [ Time Frame: 5 years ]
unit of measure: Degrees (0-360) soft tissue ANB (the angle between soft tissue nasion, A point and B point on a profile photograph)
Dentofacial development [ Time Frame: 5 years ]
unit of measure: Maxillary arch constriction score using Modified Huddart/Bodenham 25 point scoring system (-22 to +2)
Growth [ Time Frame: 12 months ]
unit of measure: nude weight in grams (g)
Growth [ Time Frame: 12 months ]
unit of measure: crown to heel length measure in centimetres (cm)
Growth [ Time Frame: 12 months ]
unit of measure: occipitofrontal circumference in centimetres (cm)

Eligibility Criteria

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Ages Eligible for Study:	up to 6 Months (Child)
Sexes Eligible for Study:	All
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
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993551

Locations


Brazil
University of Sao Paulo
Bauru, Brazil
Denmark
Copenhagen Cleft Palate Centre
Copenhagen, Denmark
Århus Speech and Hearing Institute
Århus, Denmark
Norway
Helse Bergen HF
Bergen, Norway
Oslo University Hospital
Oslo, Norway
Sweden
Göteborg University
Göteborg, Sweden
University of Linköping
Linköping, Sweden
Malmö University Hospital
Malmö, Sweden
Karolinska University Hospital
Stockholm, Sweden
Umeå University
Umeå, Sweden
Uppsala University
Uppsala, Sweden
United Kingdom
Belfast Health and Social Care Trust
Belfast, United Kingdom
Birmingham Children's NHS Foundation Trust
Birmingham, United Kingdom
North Bristol NHS Foundation Trust
Bristol, United Kingdom
Edinburgh Hospital for Sick Children
Edinburgh, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
Leeds University Hospitals NHS foundation Trust
Leeds, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
Central Manchester University Hospitals NHS Foundation Trust
Manchester, United Kingdom
Newcastle University Hospitals NHs Foundation Trust
Newcastle, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, United Kingdom
Salisbury District Hospital
Salisbury, United Kingdom
Abertawe Bro Morgannwg University Health Board
Swansea, United Kingdom

Sponsors and Collaborators

William Shaw

University of Liverpool

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators


Principal Investigator:	William C Shaw	University of Manchester

More Information


Responsible Party:	William Shaw, Professor of Orthodontics Dentofacial Development, University of Manchester
ClinicalTrials.gov Identifier:	NCT00993551 History of Changes
Other Study ID Numbers:	09-017-E 1U01DE018837-01A1 ( U.S. NIH Grant/Contract ) Sponsor Reference: 57201 ( Other Identifier: The University of Manchester (UK) ) NIHR Portfolio Reference 30200 ( Other Identifier: NIHR )
First Posted:	October 12, 2009 Key Record Dates
Last Update Posted:	November 20, 2017
Last Verified:	November 2017

Keywords provided by William Shaw, 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

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