Hearing Impaired Children Clinical Trial
Official title:
Single-stage Bone-anchored Hearing Implant Surgery in the Pediatric Population Using the BI300 Implant
Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure. This approach has several advantages since it avoids a second surgical procedure. The single-stage approach is proven to be safe and feasible in adults and is nowadays referred to as the standard surgical technique in adults. Despite favorable outcomes and advantages of the single-stage surgery, most Ear Nose Throat (ENT)-surgeons still perform two-stage surgery when inserting BAHI in the pediatric population. Therefore, the aim of this study is to compare implant loss between single-stage BAHI surgery and two-stage BAHI surgery in children aged 4 to 9 years.
General description:
A prospective comparative study with historical control group will be performed.The test
group will consist of 22 children aged 4-9 years old who are found to be suitable candidates
for treatment with a BAHI (BI300 implant and BA300 abutment). The control group consists of
approximatley 50 children, aged 4-9 years old, who already underwent insertion with a wide
diameter implant between 2012 and 2018. In the test group, BAHI insertion will be performed
using single-stage surgery. Patients in the control group already underwent BAHI insertion
using two-stage surgery.
Recruitment and consent:
All children planned for implantation with bone anchored hearing implants will be screened
for inclusion in the present study. Patients who meet the inclusion criteria will be
approached for participation by their ENT-specialist, after patients' and parents/caretakers'
approval they will be informed and screened for participation by one of the researchers. The
study protocol will be discussed with the potential study participant and his/her
parents/caretakers by the researcher. The potential study participant and his/her
parents/caretakers will be given/sent the Informed Consent Form to read. Potential study
participants will be encouraged to discuss the study with family members and personal
physician(s) before deciding whether to participate in the study. Patients and their
parents/caretakers have 14 days to consider their decision. In order to participate in the
study, both parents/caretakers need to sign the informed consent form.
Data handling:
Data captured will be recorded in Castor using electronic Case Report Forms (eCRFs). All
data, patient and product related, must be accurately recorded in the eCRF by the delegated
site staff. All users of the Castor system have personal, password protected accounts
allowing tracking of all data entry in the system. Data management and data cleaning will be
performed in the eCRF using the queries function to ensure traceability of all data entry and
changes by the assigned data manager. Data including patient identifying information (i.e.
name, initials, birth date) will be stored on a secured network drive using a code. Only the
investigator who has the code can correlate the data with the patient's name and date of
birth. It is the responsibility of the investigator to make sure that patient identification
listings with patient code and identity are kept. Raw measurement data and other data such as
historical information will be storedin the patient file, since data may be partly acquired
and/or evaluated during standard patient care to limit the amount of extra procedures and
hospital visits. For data analyses, data will be exported and stored in a digital research
environment, separate from the key to the code. After completion of the study data collection
and final monitoring visit, the electronic database will be locked and exported to SPSS
format, which will be archived for 15 years after completion of the study. The coded study
data will be archived separately from the key to the subject code in a secured digital
research environment, also for a period of 15 years.
Reporting (severe) adverse events:
The investigator will report the Severe Adverse Events (SAEs) through the web portal
ToetsingOnline to the accredited Medical Ethical Committee (METC) that approved the protocol,
within 7 days of first knowledge for SAEs that result in death or are life threatening
followed by a period of maximum of 8 days to complete the initial preliminary report. All
other SAEs will be reported within a period of maximum 15 days after the investigator has
first knowledge of the serious adverse events.
Device deficiency:
Inadequacy of an investigational medical device related to its identity, quality, durability,
reliability, safety or performance. This may include malfunctions, use error, or inadequacy
in the information supplied by the manufacturer. Device deficiency's will be logged together
with an assessment by the investigator and reported to the manufacturer where applicable.
Follow-up of adverse events:
All Adverse events (AEs) will be followed until they have abated, or until a stable situation
has been reached. Depending on the event, follow up may require additional tests or medical
procedures as indicated, and/or referral to the general physician or a medical specialist.
SAEs need to be reported until the end of study within the Netherlands, as defined in the
protocol.
Monitoring and Quality Assurance:
In accordance with the guidelines of the 'Dutch Federation of university medical centers'
(NFU) for monitoring of studies with negligible risk, a qualified monitor of another
department of the Radboudumc, who is not part of the research team of this study, will be
appointed. 28% of informed consents, 10% of inclusion and exclusion criteria (and three
subjects who were enrolled first), 10% source data verification, reported SAEs and 10% of
participants with regard to missed SAEs will be monitored.
Statistical analysis:
The main analyses will be the comparison between the test group, in which single-stage
surgery is performed and the control group undergoing two-stage surgery.
Concerning the primary outcome, the proportions of implant loss in the test and control group
will be compared using an exact binominal test and a one tailed confidence interval of 95%.
Secondary outcome measures will be compared between groups using the unpaired t-test
(normally distributed data or Mann-Whitney U tests (not normally distributed data) for
continuous variables, Mantel Haenszel chi-square test for ordered categorical variables,
Fisher's exact test for dichotomous variables and Chi-square test for non-ordered categorical
variables. If significant differences are found for baseline variables between the test group
and the control group a complementary analysis between the two groups will be performed with
adjustment for these variables.
Handling of missing data for secondary and tertiary endpoints (especially applicable for
control group data), depends on the reason why this data is missing and on the amount of
missing data. Therefore decisions on handling of missing data will be made after all data is
collected.
All tests will be performed using a confidence interval of 95% and a significance level of
0.05.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04317456 -
AChild - Austrian Children With Hearing Impairment - Longitudinal Database
|
||
Recruiting |
NCT04039802 -
Single-stage Surgery Using the BHX Implant
|
||
Not yet recruiting |
NCT06061458 -
Assessment of Children by Speech ABR
|
N/A | |
Recruiting |
NCT04962828 -
Inter Disciplinary Approach to Vocabulary Development in Hearing Impairment
|
N/A | |
Recruiting |
NCT05854719 -
Eyes On Lips? Speechreading Skills and Facial Expression Discrimination in Children With and Without Impaired Hearing
|
N/A | |
Not yet recruiting |
NCT04092231 -
Outcomes of Cochlear Implantation in Pediatrics
|
||
Completed |
NCT06354400 -
Core Stabilization Training on Chest Expansion, Functional Capacity, Trunk Muscle Endurance in Hearing-Impaired Children
|
N/A | |
Enrolling by invitation |
NCT05245799 -
Hear Me Read 2021 Clinical Trial
|
N/A | |
Not yet recruiting |
NCT04427631 -
Exploring Interventions for Glue Ear During Covid-19
|
N/A | |
Not yet recruiting |
NCT06461520 -
Effects of Maze Balance Board Training on Balance in Children With Hearing Impairment.
|
N/A | |
Not yet recruiting |
NCT06406088 -
EarGenie MVP Performance Evaluation
|
N/A | |
Not yet recruiting |
NCT04093830 -
Bimodal Stimulation Compared to Unilateral Cochlear Implant
|
N/A | |
Completed |
NCT05061069 -
Vestibular Infants Screening-Flanders
|
N/A | |
Recruiting |
NCT06317493 -
Hearing Impairment in Children: Pupillometry and Hearing Thresholds Assessment
|
||
Completed |
NCT04231396 -
Audiobooks for Hearing Loss App as Auditory Training
|
N/A | |
Completed |
NCT04691830 -
Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children
|
N/A | |
Completed |
NCT06198192 -
Effects of Pilates Exercises on Hearing Impairment Children
|
N/A | |
Completed |
NCT06198049 -
Effects of Pilates and Balance Proprioception Exercises on Hearing Impairment
|
N/A | |
Not yet recruiting |
NCT04040517 -
Auditory Steady State Response vsAuditory Brainstem Response
|
||
Not yet recruiting |
NCT05962814 -
EarGenie: Assessment of a Minimum Viable Product
|
N/A |