Timing of Primary Surgery for Cleft Palate

Cleft Palate Clinical Trial

— TOPS  

Official title:

Timing of Primary Surgery for Cleft Palate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993551
• Other study ID #: 09-017-E
• Secondary ID: 1U01DE018837-01A
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: March 26, 2021

Study information

• Verified date: August 2021
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 558
• Est. completion date: March 26, 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Palate

Intervention

Procedure:
• primary surgery for cleft palate
Surgery completed using the Sommerlad technique

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Bauru
Denmark	Århus Speech and Hearing Institute	Århus
Denmark	Copenhagen Cleft Palate Centre	Copenhagen
Norway	Helse Bergen HF	Bergen
Norway	Oslo University Hospital	Oslo
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
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	Manchester University 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

Sponsors (5)

Lead Sponsor	Collaborator
Kevin Munro	Göteborg University, National Institute of Dental and Craniofacial Research (NIDCR), University of Copenhagen, University of Liverpool

Countries where clinical trial is conducted

Brazil,  Denmark,  Norway,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure for the TOPS trial is insufficient velopharyngeal function.	Unit of measure: Sufficient (VPC sum <=3) or insufficient (VPC sum>=4). VPC sum measured on scale from 1 to 6.	5 years
Secondary	Velopharyngeal function;1.Velopharyngeal composite score summary (VPC sum) 2.Insufficient velopharyngeal function (VPC rate)	Velopharyngeal function measured by combination of VPC sum and VPC rate. VPC sum is measured as for primary outcome measure and VPC rate on a 3 point scale; insufficient, marginal or sufficient	3 and 5 years
Secondary	Velopharyngeal function: Velopharyngeal insufficiency symptoms	It will be measured either by presence of resonance "yes" within normal limit or "no" if not within normal limit	3 years
Secondary	Canonical babbling; 1.Canonical babbling present 2.Canonical babbling ratio	Canonical babbling is measured by presence of vocalised syllables and percentage ( ratio) of children vocalising canonical or non canonical babbling of syllables	12 months
Secondary	Canonical babbling; 3.Consonant inventory	Consonant inventory is measured by the number of correct sounds produced	12 months
Secondary	Articulation: 1. Percent consonant correct (PCC)	Articulation is measured by the percentage of children vocalising the correct consonants	3 and 5 years
Secondary	Articulation: 1.Percent Correct Placement (PCP) 3. Percent Correct Manner (PCM) 4. Non-oral consonant errors 5. Oral consonant errors	Articulation is measured by the percentage of children vocalising correct consonants ( oral and non-oral) in the correct placement and manner	3 and 5 years
Secondary	Postoperative/long term complications	Complications are measured by assessment for presence (yes or no) of the following:1.Dehiscence 2.Infection 3.Evidence of fistula	48 hours and 30 days postoperatively
Secondary	Postoperative/long term complications	measured by assessment for presence (yes or no) or evidence of fistula	at 3 and 5 year follow up
Secondary	Hearing: hearing level assessment	Assessment of hearing level by Tympanometry and abnormal transient otoacoustic emission (TEOAE)	12 months
Secondary	Hearing level assessment for: 1. Abnormal Puretone audiometry in one and or both ears.	Hearing level is assessed by Puretone audiometry	3 and 5 years
Secondary	Hearing level assessment	Severity of hearing loss is measured in better ear is categorised as normal, mild, moderate, severe or profound.	3 and 5 years
Secondary	Middle ear function	Middle ear function is assessed by presence of flat line Tympanogram in at least one ear and or both ears	12 months, 3 and 5 years
Secondary	Dentofacial development: Soft tissue ANB (the angle between soft tissue nasion,	Soft tissue development is measured by measuring the angle between two points (SSs-ns-sms) on a profile photograph. The unit of measure is angular degrees	5 years
Secondary	Dentofacial development; Maxillary arch constriction score	This outcome is assesed using modified Huddart/Bodenham scoring system which is a range from -24 to +8	5 years
Secondary	Growth assessment for nude weight	Growth is measured in Kg body weight in nude	12 months
Secondary	Growth Assessment for crown to heel length and occipitofrontal circumference	Assessment for crown to heel length and Occipitofrontal circumference are in centimetres.	12 months