Comparison of Different Feeding Appliances for Cleft Palate Babies
1 other identifier
interventional
30
1 country
1
Brief Summary
This study will compare flexible , rigid feeding plates and a special feeding bottle for children with cleft palate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedFirst Submitted
Initial submission to the registry
October 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 26, 2023
CompletedOctober 26, 2023
October 1, 2023
29 days
October 15, 2023
October 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
group 1 rigid feeding plate
ACTIVE COMPARATORHeat cure polymerizing acrylic resin was used to fabricate the second appliance.
group 2 flexible feeding plate
ACTIVE COMPARATOROne mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
special feeding appliance
ACTIVE COMPARATORspecial feeding bottle
Interventions
One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
Eligibility Criteria
You may qualify if:
- Infants with age range from 1-15 days.
- Unilateral cleft palate.
- Medically free subjects.
- Both males and females.
You may not qualify if:
- 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.-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
faculty of dentistry Tanta University
Tanta, +2, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amel AE salem
faculty of dentistry tanta university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor
Study Record Dates
First Submitted
October 15, 2023
First Posted
October 26, 2023
Study Start
July 1, 2023
Primary Completion
July 30, 2023
Study Completion
October 16, 2023
Last Updated
October 26, 2023
Record last verified: 2023-10