Comparison of Different Feeding Appliances for Cleft Palate Babies

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

Detailed Description
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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.

Official Title
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Comparison of Different Feeding Appliances for Cleft Palate Babies

Conditions
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Cleft Palate

Intervention / Treatment
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* Device: flexible feeding plate


Participation Criteria
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Eligibility Criteria
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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.-

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 15 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1 rigid feeding plate<br>Heat cure polymerizing acrylic resin was used to fabricate the second appliance. | Device: flexible feeding plate<br>* One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.<br>* Other names: special feeding appliance;|
| Active Comparator: group 2 flexible feeding plate<br>One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine. | Device: flexible feeding plate<br>* One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.<br>* Other names: special feeding appliance;|
| Active Comparator: special feeding appliance<br>special feeding bottle | Device: flexible feeding plate<br>* One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.<br>* Other names: special feeding appliance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feeding appliance ,flexible, rigid