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NCT06103162 Clinical Trial

Comparison of Different Feeding Appliances for Cleft Palate Babies

Cleft Palate Clinical Trial

Official title:
Comparison of Different Feeding Appliances for Cleft Palate Babies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06103162
Other study ID # #R-RP-7-23-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date October 16, 2023

Study information
Verified date October 2023
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 16, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 15 Days
Eligibility Inclusion Criteria: - Infants with age range from 1-15 days. - Unilateral cleft palate. - Medically free subjects. - Both males and females. Exclusion Criteria: - 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.-

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• flexible feeding plate
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.

Locations
Country Name City State
Egypt faculty of dentistry Tanta University Tanta

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary The feeding efficiency The measure was defined as the volume of fluid transferred per unit time, in milliliters per minute (mL/min). during 1 month
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