The key objective of this study is to determine the clinical significance of using MRI scans as a diagnostic tool to assess velopharyngeal insufficiency in cleft palate patients.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Differences in MRI-measured parameters of velopharyngeal anatomy between
patients with cleft palate and VPI, and individuals with cleft palate without
VPI. Differences in MRI-measured parameters of velopharyngeal anatomy between
patients in which speech therapy/surgical treatment is/is not successful, and
individuals with cleft palate without VPI.
Secondary outcome
Secondary study parameters include the same research questions as described
with regard to MRI measured parameters on velopharyngeal anatomy, applied to
nasometry, speech test, nasendoscopy, oral inspection and PROMs outcomes.
Background summary
20-30% of children with a history of cleft palate repair develop velopharyngeal
insufficiency (VPI). VPI is defined as inadequate closure of the soft palate to
the posterior pharyngeal wall, resulting in hypernasality, nasal air emission
and reduced speech loudness. The current golden standard in The Netherlands for
assessment of VPI consists of speech tests and nasoendoscopy. However, these
diagnostic tools mainly provide subjective information on velar anatomy and
function. It does not allow for assessment of the position and function of the
velar muscles, which have a large effect on velar function and therefore on
speech. In the literature, magnetic resonance imaging (MRI) has been proposed
for direct evaluation of the gap size between the soft palate and the posterior
pharyngeal wall, velar mobility and the location of the velar muscles that play
a role in VPI. MRI is non-invasive and free of radiation exposure. Furthermore,
it has proven to be a child-friendly, reproducible, and repeatable method
providing a three-dimensional view of the velopharyngeal structures and
function during speech4 and is currently used in numerous cleft units in the
United States. We believe that implementing MRI-scans in our standard care will
improve health care for children with VPI and could influence our cleft palate
surgery technique.
Study objective
The key objective of this study is to determine the clinical significance of
using MRI scans as a diagnostic tool to assess velopharyngeal insufficiency in
cleft palate patients.
Study design
Monocenter, prospective cohort study.
Study burden and risks
The standard care consists of visits to the outpatient clinic, speech and
language tests and nasoendoscopy. In this study, the participants will have to
fill out two short surveys and visit the outpatient clinic one extra time in
order to have the MRI scan. The risk of physical harm in unsedated MRI is very
low6, and unsedated MRI without contrast agents in paediatrics meets the
minimal-risk standard. In paediatric populations, the risk of considerable fear
and discomfort with regard to an MRI scan is also low6. Furthermore, in case of
anxiety, and aged under six years, children will be referred in order to
receive additional child-friendly explanation and preparation prior to the
scan. The additional information obtained with the MRI scans could lead to
improved diagnosis and treatment of VPI amongst the study population.
VPI is usually diagnosed and treated at the age of 4-9 years. Treatment is of
great importance due to the substantial morbidity and developmental delay VPI
could cause due to impairment of the child*s ability to communicate in both
social and educational settings. Therefore, clinically significant VPI is
extremely rare amongst adults and this study will have to be carried out with
minors.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- >4 years of age
- History of non-syndromic unilateral cleft lip and palate (UCLP)
- History of cleft palate repair (Von Langenbeck technique)
- No history of secondary palate surgery
- Hypernasality
- Informed consent
- Patient <12 years of age: informed consent required from parent(s)/legal
guardian(s)
- Patients 12-16 years of age: informed consent required from both patient and
parent(s)/legal guardian(s)
- Patient >16 years of age: informed consent required from patient
- Patient can be well instructed with regard to the MRI scan
Exclusion criteria
- <4 years of age
- Syndromes
- No history of UCLP
- Primary cleft palate repair with other technique than Von Langenbeck
- History of secondary palate surgery
- No hypernasality
- No informed consent
- Non removable orthodontic device
- Patient cannot be well instructed with regard to the MRI scan
- Any exclusion criteria regarding the MRI scan
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86277.018.24 |