Cleft Palate ChildrenSPEACNCT03995199
A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow-Sommerlad Palatoplasty in Comparison to Modified Furlow Palatoplasty Alone
An observational study of Cleft Palate Children, run by AZ Sint-Jan AV at 1 site in Belgium.
Trial summary
Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. Read more about this study
- Who is it for?
- Ages 5 to 7 years
- Conditions the study is for
- Cleft Palate Children
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Sep 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Child
Study population: Patients with a clinically diagnosed cleft of the hard and/or soft palatum, that are treated surgically with a modified Furlow palatoplasty or a modified Furlow palatoplasty in combination with an intravelar veloplasty by Sommerlad. Patients should receive their postoperative care and annual speech evaluation by the cleft team of the AZ Sint-Jan Brugge-Oostende av.
Who may be able to join
- Patients should have a clinically diagnosed cleft of the hard and/or soft palatum, with or without involvement of the lip or nose (Veau classification I to IV (see Appendix 1).
- Patients should have undergone a modified Furlow palatoplasty or modified Furlow according to Sommerlad in the AZ Sint-Jan Brugge-Oostende av
- Patients should receive their postoperative care and speech therapy by the cleft team of the general hospital Sint-Jan Bruges
- Patients should be in the fifth life year at time of speech evaluation
- Patients should be Dutch-speaking as a maternal language
Who cannot join
- Patients not meeting the abovementioned inclusion criteria
- Patients that received a corrective surgical procedure for velopharyngeal dysfunction after the modified Furlow technique alone, or in combination with the intravelar veloplasty by Sommerlad
- Patients that are bi- or multilingual
- Patients with clinically diagnosed mild hearing difficulties (i.e. ASHA classification: hearing loss >25dB)30
- Patients with a clinically diagnosed stutter
- Patients with clinically diagnosed cognitive and/or motoric disabilities
- Patients that received intensive speech therapy prior to their fifth life year can be included, but will be analyzed separately(subgroup analysis)
- Note: The number of patients with a uni- or bilateral cleft involving the lip or nose should be comparable between both groups, since this can interfere with speech and could bias comparison of speech outcome between different cleft subgroups.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Division of oral and maxillofacial surgery, Department of Surgery, AZ Sint-Jan Brugge-Oostende AV
Bruges
About this study
Official title: A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow Palatoplasty in Combination With Intravelar Veloplasty According to Sommerlad, or Modified Furlow Palatoplasty Alone
Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. The investigators aim to evaluate if the surgical modified Furlow palatoplasty in combination with the intravelar veloplasty according to Sommerlad significantly reduces the number of pediatric patients with abnormal speech between five and seven years of age, as measured with the four-point scale recently published by Nguyen et al.(2015), in comparison to the conventional modified Furlow technique.
study design A prospective cohort trial. All cleft palate patients surgically treated with a modified Furlow technique since January 2012 or a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad routinely undergo an annual speech evaluation by the speech language pathologist of the cleft team. At the age of five, eligible patients that are in continuous follow-up by the cleft team at our hospital, will be asked for consent to register their demographic, surgical and speech-related data. In addition, the parents of cleft patients will be asked to complete a quality of life questionnaire concerning their child, at the time of speech evaluation through self-report or through an interview with the clinical research coordinator.
Read more
The investigators hypothesise that the combined modified Furlow and Sommerlad palatoplasty leads to a minimal 50% reduction in the proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015), compared to patients that underwent a Modified Furlow technique alone.
conclusion Although the technique by Sommerlad has shown promising results, prospective trials comparing postoperative speech outcome after different surgical techniques, are lacking. The present trial could offer objective results to validate the current surgical treatment protocol implemented at our department.
Read the detailed description
Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. The investigators aim to evaluate if the surgical modified Furlow palatoplasty in combination with the intravelar veloplasty according to Sommerlad significantly reduces the number of pediatric patients with abnormal speech between five and seven years of age, as measured with the four-point scale recently published by Nguyen et al.(2015), in comparison to the conventional modified Furlow technique.
study design A prospective cohort trial. All cleft palate patients surgically treated with a modified Furlow technique since January 2012 or a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad routinely undergo an annual speech evaluation by the speech language pathologist of the cleft team. At the age of five, eligible patients that are in continuous follow-up by the cleft team at our hospital, will be asked for consent to register their demographic, surgical and speech-related data. In addition, the parents of cleft patients will be asked to complete a quality of life questionnaire concerning their child, at the time of speech evaluation through self-report or through an interview with the clinical research coordinator.
The investigators hypothesise that the combined modified Furlow and Sommerlad palatoplasty leads to a minimal 50% reduction in the proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015), compared to patients that underwent a Modified Furlow technique alone.
conclusion Although the technique by Sommerlad has shown promising results, prospective trials comparing postoperative speech outcome after different surgical techniques, are lacking. The present trial could offer objective results to validate the current surgical treatment protocol implemented at our department.
- Conditions
- Cleft Palate Children
- Keywords
- speech evaluation, modified Furlow palatoplasty, Sommerlad intravelar veloplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Furlow group | All cleft palate patients surgically treated with a modified Furlow technique since January 2012 | |
| Furlow + Sommerlad group | All cleft palate patients surgically treated with a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015)
proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015)
Measured: at time of routine speech evaluation between age 5-7 years old
Secondary outcomes (5)
prevalence of speech problems, as defined by the perceptual evaluation
prevalence of speech problems, as defined by the perceptual evaluation
Measured: at time of routine speech evaluation between age 5-7 years old
prevalence of speech problems, as defined by the objective speech evaluation (nasometry)
prevalence of speech problems, as defined by the objective speech evaluation (nasometry)
Measured: at time of routine speech evaluation between age 5-7 years old
incidence of 30-day postoperative complications
incidence of 30-day postoperative complications
Measured: within 30 days postoperative
PVRQOL questionnaire, as a measure of quality of life
PVRQOL questionnaire, as a measure of quality of life
Measured: at time of routine speech evaluation between age 5-7 years old
COHIP questionnaire, as a measure of quality of life
COHIP questionnaire, as a measure of quality of life
Measured: at time of routine speech evaluation between age 5-7 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start13 Sep 2017
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krisztian Nagy, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995199
- Sponsor's protocol ID
- B049201629483
- Acronym
- SPEAC
- Status last verified
- Feb 2022
- First submitted
- 19 Jun 2019
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Speech Outcome in Pediatric Cleft Patients, After Modified Furlow Palatoplasty in Combination With Intravelar Veloplasty According to Sommerlad, or Modified Furlow Palatoplasty Alone
- ClinicalTrials.gov ID
- NCT03995199
- Acronym / sponsor ID
- SPEAC / B049201629483
- Conditions
- Cleft Palate Children
- Keywords
- speech evaluation, modified Furlow palatoplasty, Sommerlad intravelar veloplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. The investigators aim to evaluate if the surgical modified Furlow palatoplasty in combination with the intravelar veloplasty according to Sommerlad significantly reduces the number of pediatric patients with abnormal speech between five and seven years of age, as measured with the four-point scale recently published by Nguyen et al.(2015), in comparison to the conventional modified Furlow technique.
study design A prospective cohort trial. All cleft palate patients surgically treated with a modified Furlow technique since January 2012 or a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad routinely undergo an annual speech evaluation by the speech language pathologist of the cleft team. At the age of five, eligible patients that are in continuous follow-up by the cleft team at our hospital, will be asked for consent to register their demographic, surgical and speech-related data. In addition, the parents of cleft patients will be asked to complete a quality of life questionnaire concerning their child, at the time of speech evaluation through self-report or through an interview with the clinical research coordinator.
The investigators hypothesise that the combined modified Furlow and Sommerlad palatoplasty leads to a minimal 50% reduction in the proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015), compared to patients that underwent a Modified Furlow technique alone.
conclusion Although the technique by Sommerlad has shown promising results, prospective trials comparing postoperative speech outcome after different surgical techniques, are lacking. The present trial could offer objective results to validate the current surgical treatment protocol implemented at our department.
Detailed description
Nowadays, surgical success of cleft palate patients is ascribed to the sufficiency of velopharyngeal closure, and the associated speech results such as voice nasality, resonance and articulation. The investigators aim to evaluate if the surgical modified Furlow palatoplasty in combination with the intravelar veloplasty according to Sommerlad significantly reduces the number of pediatric patients with abnormal speech between five and seven years of age, as measured with the four-point scale recently published by Nguyen et al.(2015), in comparison to the conventional modified Furlow technique.
study design A prospective cohort trial. All cleft palate patients surgically treated with a modified Furlow technique since January 2012 or a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad routinely undergo an annual speech evaluation by the speech language pathologist of the cleft team. At the age of five, eligible patients that are in continuous follow-up by the cleft team at our hospital, will be asked for consent to register their demographic, surgical and speech-related data. In addition, the parents of cleft patients will be asked to complete a quality of life questionnaire concerning their child, at the time of speech evaluation through self-report or through an interview with the clinical research coordinator.
The investigators hypothesise that the combined modified Furlow and Sommerlad palatoplasty leads to a minimal 50% reduction in the proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015), compared to patients that underwent a Modified Furlow technique alone.
conclusion Although the technique by Sommerlad has shown promising results, prospective trials comparing postoperative speech outcome after different surgical techniques, are lacking. The present trial could offer objective results to validate the current surgical treatment protocol implemented at our department.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furlow group | – | –All cleft palate patients surgically treated with a modified Furlow technique since January 2012 |
| Furlow + Sommerlad group | – | –All cleft palate patients surgically treated with a modified Furlow technique in combination with an intravelar veloplasty by Sommerlad |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Patients with a clinically diagnosed cleft of the hard and/or soft palatum, that are treated surgically with a modified Furlow palatoplasty or a modified Furlow palatoplasty in combination with an intravelar veloplasty by Sommerlad. Patients should receive their postoperative care and annual speech evaluation by the cleft team of the AZ Sint-Jan Brugge-Oostende av.
Key inclusion criteria (5 listed)
- Patients should have a clinically diagnosed cleft of the hard and/or soft palatum, with or without involvement of the lip or nose (Veau classification I to IV (see Appendix 1).
- Patients should have undergone a modified Furlow palatoplasty or modified Furlow according to Sommerlad in the AZ Sint-Jan Brugge-Oostende av
- Patients should receive their postoperative care and speech therapy by the cleft team of the general hospital Sint-Jan Bruges
- Patients should be in the fifth life year at time of speech evaluation
- Patients should be Dutch-speaking as a maternal language
Key exclusion criteria (8 listed)
- Patients not meeting the abovementioned inclusion criteria
- Patients that received a corrective surgical procedure for velopharyngeal dysfunction after the modified Furlow technique alone, or in combination with the intravelar veloplasty by Sommerlad
- Patients that are bi- or multilingual
- Patients with clinically diagnosed mild hearing difficulties (i.e. ASHA classification: hearing loss >25dB)30
- Patients with a clinically diagnosed stutter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015)
Time frame: at time of routine speech evaluation between age 5-7 years old
proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015)
5 secondary outcomes
prevalence of speech problems, as defined by the perceptual evaluation
Time frame: at time of routine speech evaluation between age 5-7 years old
prevalence of speech problems, as defined by the objective speech evaluation (nasometry)
Time frame: at time of routine speech evaluation between age 5-7 years old
incidence of 30-day postoperative complications
Time frame: within 30 days postoperative
PVRQOL questionnaire, as a measure of quality of life
Time frame: at time of routine speech evaluation between age 5-7 years old
COHIP questionnaire, as a measure of quality of life
Time frame: at time of routine speech evaluation between age 5-7 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Palate Children, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Araceli Diez-Fraile (+32 5045 9660, araceli.diez-fraile@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of children with abnormal speech, as defined by the four-point scale recently published by Nguyen et al.(2015) (time frame: at time of routine speech evaluation between age 5-7 years old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.