Cleft PalateNCT06103162
Comparison of Different Feeding Appliances for Cleft Palate Babies
A study testing flexible feeding plate in people with Cleft Palate, run by Tanta University at 1 site in Egypt.
Trial summary
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate. Read more about this study
- Who is it for?
- Ages 1 day to 15 daysHealthy volunteers can take part
- Conditions the study is for
- Cleft Palate
- What is being tested?
- flexible feeding plate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 16 Oct 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 15 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with age range from 1-15 days.
- Unilateral cleft palate.
- Medically free subjects.
- Both males and females.
Who cannot join
- Patients older than 15 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- Patients with bilateral cleft lip and palate.
- Patients with previous presurgical infant orthopedic treatment.
- Medically compromised patients.-
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.
Read the detailed description
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.
The purpose of the present study will be explained to the patient's parents and informed consent will be obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
- Conditions
- Cleft Palate
- Being tested
- flexible feeding plate
- Keywords
- feeding appliance ,flexible, rigid
- Medical subject headings
- Cleft Palate, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible feeding plateDevice
Also called special feeding appliance
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
| Study group | Role | What they receive |
|---|---|---|
| group 1 rigid feeding plate | Active comparator | Heat cure polymerizing acrylic resin was used to fabricate the second appliance. Receives: Device: flexible feeding plate |
| group 2 flexible feeding plate | Active comparator | One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine. Receives: Device: flexible feeding plate |
| special feeding appliance | Active comparator | special feeding bottle Receives: Device: flexible feeding plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feeding efficiency
The measure was defined as the volume of fluid transferred per unit time, in milliliters per minute (mL/min).
Measured: during 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jul 2023
- Primary completion30 Jul 2023
- Study completion16 Oct 2023
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 Tanta 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
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amel Salem, Tanta University
- Investigators
- Amel AE salem, Principal investigator, faculty of dentistry tanta university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103162
- Sponsor's protocol ID
- #R-RP-7-23-2
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Feeding Appliances for Cleft Palate Babies
- ClinicalTrials.gov ID
- NCT06103162
- Acronym / sponsor ID
- #R-RP-7-23-2
- Conditions
- Cleft Palate
- Keywords
- feeding appliance ,flexible, rigid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 26 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.
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.
Detailed description
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.
The purpose of the present study will be explained to the patient's parents and informed consent will be obtained according to the guidelines on human research adopted by the Research Ethics Committee, Faculty of Dentistry, Tanta University.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 rigid feeding plate | Active comparator | Device: flexible feeding plateHeat cure polymerizing acrylic resin was used to fabricate the second appliance. |
| group 2 flexible feeding plate | Active comparator | Device: flexible feeding plateOne mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine. |
| special feeding appliance | Active comparator | Device: flexible feeding platespecial feeding bottle |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants with age range from 1-15 days.
- Unilateral cleft palate.
- Medically free subjects.
- Both males and females.
Key exclusion criteria (5 listed)
- Patients older than 15 days.
- Syndromic patients with other defects in addition to cleft lip and palate.
- Patients with bilateral cleft lip and palate.
- Patients with previous presurgical infant orthopedic treatment.
- Medically compromised patients.-
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 |
|---|---|---|
| flexible feeding plateAlso: special feeding applianceOne mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine. | Device | group 1 rigid feeding plate, group 2 flexible feeding plate, special feeding appliance |
Primary outcome
The feeding efficiency
Time frame: during 1 month
The measure was defined as the volume of fluid transferred per unit time, in milliliters per minute (mL/min).
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 26 Oct 2023.
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Furlow With Buccinator and Fistula Formation
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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.
Amel AE salem principal investigator
faculty of dentistry tanta university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible feeding plate in people with Cleft Palate, run by Tanta 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 4 inclusion and 5 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 26 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?
The feeding efficiency (time frame: during 1 month). 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 26 Oct 2023.