Cleft PalateNCT00779961
An Investigation for the Optimal Timing of a Cleft Palate Repair
A study testing Palatoplasty in people with Cleft Palate, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. The objective of this study is to determine the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids) routine palatal repair in isolated cleft palate… Read more about this study
- Who is it for?
- Ages 1 day to 5 months
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Palatoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2008to Dec 2023
- Phase
- Interventional
- 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 1 day to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant diagnosed with non-syndromic isolated unrepaired cleft involving the secondary palate.
- Between newborn and 5 months of age (pre-palate surgical assessment/ consultation.
- Treated at SickKids.
Who cannot join
- If they are non-Ontario residents;
- If they have clinical features suggestive of an associated syndrome and/or an associated syndrome;
- If they have Pierre Robin sequence;
- If the palate repair cannot be performed before 15 months of age;
- If the extent of clefting is limited to the primary palate or submucous cleft of the soft palate;
- If the child have a combined cleft lip and palate diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
The effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. The objective of this study is to determine the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids) routine palatal repair in isolated cleft palate patients by comparing speech development, velopharyngeal functioning and facial growth outcomes. The null hypothesis is no difference in speech development, velopharyngeal functioning and facial growth between early palatal repair and SickKids routine palatal repair in isolated cleft palate patients.
Read the detailed description
The goals of palatoplasty are to provide an intact palate and to create a normally functioning velopharyngeal mechanism as early as possible without hazard to other aspects of health and development. Two major criteria by which the success of cleft palate surgery is determined are subsequent speech development and facial growth. Therefore, the debate about timing of cleft palate surgery is focused on the need for early palatoplasty for speech purposes versus later palatoplasty to ensure undisturbed facial growth. A compromise solution to this controversy was proposed by Schweckendiek; the soft palate is repaired at an early age leaving the hard palate cleft unrepaired until later in life. The premise is that primary veloplasty will result in a functioning velopharyngeal mechanism for early speech development, while the unrepaired hard palate will allow unrestricted maxillary growth. The speech outcomes of patients who have undergone delayed stage palate repair have been addressed in several studies and case series. However, there is little evidence to support the benefits of delayed stage repair with respect to facial growth and speech development. Results from published studies have shown the speech results to be relatively poor and fistula rates as unacceptably high. These results have lead a vast majority of North American surgeons to favour primary one-stage repair. Yet, the optimum timing of primary palate repair remains unknown. No randomized control trials or prospective cohort studies have been conducted to address this question.
- Conditions
- Cleft Palate
- Being tested
- Palatoplasty
- Keywords
- pediatric, cleft palate, plastic surgery, palatoplasty, pharyngoplasty
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalatoplastyProcedure or surgery
Routine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
PalatoplastyProcedure or surgery
Palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Early Cleft Palate Repair (Age group 6-10 months) Receives: Procedure: Palatoplasty |
| Group B | Active comparator | Sick Kids Routine cleft palate repair (age group 10-14 months) Receives: Procedure: Palatoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age.
Measured: 5 years
Secondary outcomes (3)
Surgical Complications: Surgical complications (i.e. fistula and dehiscence) will be evaluated between 6-8 weeks post-operatively and recorded.
Measured: 6-8 weeks post-op
Feeding Assessment: A feeding assessment will be conducted pre-surgery (5 months of age) and post surgery (6-8 weeks post-operatively).
Measured: 6-8 weeks post-op
Dental and Facial Growth Disturbances measured in patients with isolated secondary plate cleft by analysis of the severity of their malocclusion,and performing a lateral cephalometric analysis
Measured: 5 years of age, 11-13 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Fisher, The Hospital for Sick Children
- Investigators
- David M Fisher, MD, FRCSC, Principal investigator, The Hospital for Sick Children, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00779961
- Sponsor's protocol ID
- 1000010915
- Status last verified
- Mar 2022
- First submitted
- 23 Oct 2008
- Last updated
- 24 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation for the Optimal Timing of a Cleft Palate Repair
- ClinicalTrials.gov ID
- NCT00779961
- Acronym / sponsor ID
- 1000010915
- Conditions
- Cleft Palate
- Keywords
- pediatric, cleft palate, plastic surgery, palatoplasty, pharyngoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Oct 2008 (estimated)
- 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.
The effect of timing of cleft palate repair on speech development, velopharyngeal functioning, and facial growth remains unknown. The objective of this study is to determine the effectiveness of early palatal repair versus The Hospital for Sick Children (SickKids) routine palatal repair in isolated cleft palate patients by comparing speech development, velopharyngeal functioning and facial growth outcomes. The null hypothesis is no difference in speech development, velopharyngeal functioning and facial growth between early palatal repair and SickKids routine palatal repair in isolated cleft palate patients.
Detailed description
The goals of palatoplasty are to provide an intact palate and to create a normally functioning velopharyngeal mechanism as early as possible without hazard to other aspects of health and development. Two major criteria by which the success of cleft palate surgery is determined are subsequent speech development and facial growth. Therefore, the debate about timing of cleft palate surgery is focused on the need for early palatoplasty for speech purposes versus later palatoplasty to ensure undisturbed facial growth. A compromise solution to this controversy was proposed by Schweckendiek; the soft palate is repaired at an early age leaving the hard palate cleft unrepaired until later in life. The premise is that primary veloplasty will result in a functioning velopharyngeal mechanism for early speech development, while the unrepaired hard palate will allow unrestricted maxillary growth. The speech outcomes of patients who have undergone delayed stage palate repair have been addressed in several studies and case series. However, there is little evidence to support the benefits of delayed stage repair with respect to facial growth and speech development. Results from published studies have shown the speech results to be relatively poor and fistula rates as unacceptably high. These results have lead a vast majority of North American surgeons to favour primary one-stage repair. Yet, the optimum timing of primary palate repair remains unknown. No randomized control trials or prospective cohort studies have been conducted to address this question.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: PalatoplastyEarly Cleft Palate Repair (Age group 6-10 months) |
| Group B | Active comparator | Procedure: PalatoplastySick Kids Routine cleft palate repair (age group 10-14 months) |
Who may qualify
- Ages
- 1 day to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infant diagnosed with non-syndromic isolated unrepaired cleft involving the secondary palate.
- Between newborn and 5 months of age (pre-palate surgical assessment/ consultation.
- Treated at SickKids.
Key exclusion criteria (6 listed)
- If they are non-Ontario residents;
- If they have clinical features suggestive of an associated syndrome and/or an associated syndrome;
- If they have Pierre Robin sequence;
- If the palate repair cannot be performed before 15 months of age;
- If the extent of clefting is limited to the primary palate or submucous cleft of the soft palate;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalatoplastyRoutine palatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids | Procedure or surgery | Group A |
| PalatoplastyPalatoplasty will be performed under the supervision of one of five surgeons within the Division of Plastic Surgery at Sick Kids | Procedure or surgery | Group B |
Primary outcome
The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age.
Time frame: 5 years
3 secondary outcomes
Surgical Complications: Surgical complications (i.e. fistula and dehiscence) will be evaluated between 6-8 weeks post-operatively and recorded.
Time frame: 6-8 weeks post-op
Feeding Assessment: A feeding assessment will be conducted pre-surgery (5 months of age) and post surgery (6-8 weeks post-operatively).
Time frame: 6-8 weeks post-op
Dental and Facial Growth Disturbances measured in patients with isolated secondary plate cleft by analysis of the severity of their malocclusion,and performing a lateral cephalometric analysis
Time frame: 5 years of age, 11-13 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
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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.
David M Fisher, MD, FRCSC principal investigator
The Hospital for Sick Children, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palatoplasty in people with Cleft Palate, run by The Hospital for Sick Children at 1 site in Canada.
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 3 inclusion and 6 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 24 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be determined by the presence/absence of Velopharyngeal Insufficiency (VPI) at 5 years of age. (time frame: 5 years). 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 24 Mar 2022.