Cleft Lip and PalateNCT06075069
Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function
A study testing Feeding appliance in people with Cleft Lip and Palate, run by Alexandria University at 1 site in Egypt.
Trial summary
Aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Feeding appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 10 May 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with bilateral cleft lip and palate.
- Centralized pre-maxilla that does not need active appliance.
- Normal inner ear and auditory nerve function.
Who cannot join
- Infant with unilateral cleft lip and palate or cleft palate only.
- Deviated pre-maxilla that needs active appliance.
- Congenital hearing problems or sensorineural hearing loss/
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function: Clinical Trial
Aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function
- Conditions
- Cleft Lip and Palate
- Being tested
- Feeding appliance
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding applianceDevice
A preliminary alginate impression was made using wax stock tray to get a preliminary cast and construct a self-cure acrylic custom-made tray. A Medium viscosity rubber base impression material was used for making final impression which in turn will be poured to obtain a master cast. On this master cast, a feeding appliance will be constructed. Readymade facebow with two straight side length of hard, rounded, of 2mm diameter, 15cm length Nickel-Chrome wire with omega loops (at the end of the wire) was used to form extra-oral wings to be used as a retentive aid to maintain the prosthesis in situ. The appliance was fabricated in clear acrylic resin then finished and polished. A small piece of cold cure acrylic resin was added and adapted to the omega loops and manipulated to follow the checks contour.
| Study group | Role | What they receive |
|---|---|---|
| Feeding appliance immediately after birth | Experimental | Not described Receives: Device: Feeding appliance |
| Feeding appliance after 1-3 months | Experimental | Not described Receives: Device: Feeding appliance |
| Feeding appliance after 4 -12 months | Experimental | Not described Receives: Device: Feeding appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of middle ear pressure
This was performed using Tympanometer that measures the air pressure in the middle ear to obtain Tympanogram which is a graphic representation of how the eardrum moves in response to the air pressure in the ear canal. Tympanometry was performed using a AT235 tympanometer with a 226-Hz probe frequency. It was calibrated to ANSI standards (American National Standards Institute,1987).
The normal middle-ear pressure values for children are +50 daPa to -200 daPa.
Measured: up to one year of age
Assessment of middle ear compliance
This was performed using Tympanometer.
The patients' tympanometric results were classified into three types:
- Type A: Static compliance greater than 0.1 ml and the point of greatest compliance is at approximately 0 daPa; the curve is shown by a large, inverted V. In a "type A" curve, the peak compliance occurs at or near atmospheric pressure indicating normal pressure within the middle ear.
- Type B: The point of greatest compliance cannot be found, and the curve is shown by a flat curve (no peak). This is indicative of non-compressible fluid within the middle ear space (otitis media), tympanic membrane perforation, or debris within the external ear canal.
- Type C: Static compliance greater than or equal to 0.2 ml, and the peak compliance is significantly below zero (usually less than -200), indicating negative pressure (sub-atmospheric) within the middle ear space.
Type A tympanograms were classified as normal, but types B and C were considered abnormal
Measured: up to one year of age
Assessment of hearing quality
Audiometric screening will be performed using Auditory brainstem response (ABR) conducted under natural sleep as far as possible. ABR can provide information about the softest level of sound the ear can hear. It is traditionally used to determine the degree of hearing loss in pediatrics.
ABR test uses electrodes attached with adhesive to the baby's scalp. While the baby is sleeping, clicking sounds were made through headphones over the baby's ears. The test measures the brain's activity in response to the sounds.
Hearing level thresholds as estimated by ABR are categorized as normal (25 - 35 dB nHL), mild (35 - 45 dB nHL), moderate (45 - 65 dB nHL), severe (65 - 90 dB nHL), and profound (90 dB nHL) hearing loss.
Measured: up to one year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Oct 2021
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamel Salah, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075069
- Sponsor's protocol ID
- #111
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function: Clinical Trial
- ClinicalTrials.gov ID
- NCT06075069
- Acronym / sponsor ID
- #111
- Conditions
- Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 10 Oct 2023 (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.
Aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Feeding appliance immediately after birth | Experimental | Device: Feeding appliance |
| Feeding appliance after 1-3 months | Experimental | Device: Feeding appliance |
| Feeding appliance after 4 -12 months | Experimental | Device: Feeding appliance |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with bilateral cleft lip and palate.
- Centralized pre-maxilla that does not need active appliance.
- Normal inner ear and auditory nerve function.
Key exclusion criteria (3 listed)
- Infant with unilateral cleft lip and palate or cleft palate only.
- Deviated pre-maxilla that needs active appliance.
- Congenital hearing problems or sensorineural hearing loss/
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 |
|---|---|---|
| Feeding applianceA preliminary alginate impression was made using wax stock tray to get a preliminary cast and construct a self-cure acrylic custom-made tray. A Medium viscosity rubber base impression material was used for making final impression which in turn will be poured to obtain a master cast. On this master cast, a feeding appliance will be constructed. Readymade facebow with two straight side length of hard, rounded, of 2mm diameter, 15cm length Nickel-Chrome wire with omega loops (at the end of the wire) was used to form extra-oral wings to be used as a retentive aid to maintain the prosthesis in situ. The appliance was fabricated in clear acrylic resin then finished and polished. A small piece of cold cure acrylic resin was added and adapted to the omega loops and manipulated to follow the checks contour. | Device | Feeding appliance after 1-3 months, Feeding appliance after 4 -12 months, Feeding appliance immediately after birth |
Primary outcome
Assessment of middle ear pressure
Time frame: up to one year of age
This was performed using Tympanometer that measures the air pressure in the middle ear to obtain Tympanogram which is a graphic representation of how the eardrum moves in response to the air pressure in the ear canal. Tympanometry was performed using a AT235 tympanometer with a 226-Hz probe frequency. It was calibrated to ANSI standards (American National Standards Institute,1987). The normal middle-ear pressure values for children are +50 daPa to -200 daPa.
Assessment of middle ear compliance
Time frame: up to one year of age
This was performed using Tympanometer. The patients' tympanometric results were classified into three types: * Type A: Static compliance greater than 0.1 ml and the point of greatest compliance is at approximately 0 daPa; the curve is shown by a large, inverted V. In a "type A" curve, the peak compliance occurs at or near atmospheric pressure indicating normal pressure within the middle ear. * Type B: The point of greatest compliance cannot be found, and the curve is shown by a flat curve (no peak). This is indicative of non-compressible fluid within the middle ear space (otitis media), tympanic membrane perforation, or debris within the external ear canal. * Type C: Static compliance greater than or equal to 0.2 ml, and the peak compliance is significantly below zero (usually less than -200), indicating negative pressure (sub-atmospheric) within the middle ear space. Type A tympanograms were classified as normal, but types B and C were considered abnormal
Assessment of hearing quality
Time frame: up to one year of age
Audiometric screening will be performed using Auditory brainstem response (ABR) conducted under natural sleep as far as possible. ABR can provide information about the softest level of sound the ear can hear. It is traditionally used to determine the degree of hearing loss in pediatrics. ABR test uses electrodes attached with adhesive to the baby's scalp. While the baby is sleeping, clicking sounds were made through headphones over the baby's ears. The test measures the brain's activity in response to the sounds. Hearing level thresholds as estimated by ABR are categorized as normal (25 - 35 dB nHL), mild (35 - 45 dB nHL), moderate (45 - 65 dB nHL), severe (65 - 90 dB nHL), and profound (90 dB nHL) hearing loss.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding appliance in people with Cleft Lip and Palate, run by Alexandria University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 10 Oct 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of middle ear pressure (time frame: up to one year of age). The study lists 3 primary outcomes in all. 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 10 Oct 2023.