Unidirectional Feeding Valves for Cleft Palate
What You Need to Know Before You Apply
What is the purpose of this trial?
This study aims to assess the impact of using a cleft-adapted bottle with a unidirectional valve compared with a non-cleft-adapted bottle on oral volume intake and milk transfer rate.
Who Is on the Research Team?
Jessica L Chee-Williams, MS
Principal Investigator
Phoenix Children's Hospital
Are You a Good Fit for This Trial?
This trial is for infants who have a cleft palate or both cleft lip and palate. The study focuses on babies needing help with feeding due to these conditions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Unidirectional feeding valve
Trial Overview
The trial compares a special bottle with a one-way valve designed for babies with cleft palates against regular bottles, to see which helps infants drink more milk and feed better.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Infants randomized to the experimental group will complete an observed bottle-feeding session using a cleft-adapted bottle system with a unidirectional valve. The valve is designed to support milk transfer by allowing milk to flow toward the nipple while limiting backflow into the bottle. Milk volume intake, milk transfer rate, and feeding proficiency will be measured during the observed feeding session. Caregivers will also rate their infant's feeding quality following the session.
Infants randomized to the comparator group will complete an observed bottle-feeding session using a bottle system without a unidirectional valve. Infants will rely on their own sucking ability and compression of the nipple to transfer milk. Milk volume intake, milk transfer rate, and feeding proficiency will be measured during the observed feeding session. Caregivers will also rate their infant's feeding quality following the session.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Phoenix Children's Hospital
Lead Sponsor
University of Arizona
Collaborator
American Speech-Language-Hearing Foundation
Collaborator
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