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OpenTrials
Completed

NCT Number: NCT06103162

Comparison of Different Feeding Appliances for Cleft Palate Babies

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.-

Treatment and study plan

flexible feeding plate

Device

One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.

Other names: special feeding appliance

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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