Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
1 other identifier
interventional
35
1 country
1
Brief Summary
A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2020
CompletedFirst Submitted
Initial submission to the registry
November 3, 2020
CompletedFirst Posted
Study publicly available on registry
November 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2021
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedAugust 14, 2023
August 1, 2023
1.2 years
November 3, 2020
January 8, 2023
August 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Tube Dislodgements Per 10 Tube Days.
The number of times the tube is dislodged for every 10 days of feeding tubes.
10 days
Study Arms (2)
Nasal bridle to secure feeding tube
ACTIVE COMPARATORThe nasal bridle will be used to secure the nasoenteric feeding tube.
Adhesive Tape use to secure feeding tube
PLACEBO COMPARATORAdhesive tape will be used as standard of care to secure the nasoenteric feeding tube.
Interventions
A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
Adhesive tape used to secure nasoenteric tube
Eligibility Criteria
You may qualify if:
- Need for nasoenteric feeding
- Admitted to University Hospital
- Age 0-18 years
You may not qualify if:
- Facial trauma
- Nasal airway obstructions
- Thrombocytopenia (\<100 K/μL)
- s/p septoplasty
- Patients with vomer bone graft
- Nasoenteric feeding tube placed and secured prior to being screened for study
- Contraindication for the use of the BridlePro
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Health System
San Antonio, Texas, 78229, United States
Related Publications (1)
Foster M, Armijo-Garcia V, Gelfond J, Meyer AD. Improving retention of pediatric feeding tubes with a nasal bridle: a randomized controlled trial. Trials. 2025 May 14;26(1):159. doi: 10.1186/s13063-025-08867-x.
PMID: 40369642DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Veronica Armijo-Garcia
- Organization
- University of Texas Health Science Center at San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Veronica Armijo, MD
University of Texas Health at San Antonio
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2020
First Posted
November 9, 2020
Study Start
February 18, 2020
Primary Completion
April 30, 2021
Study Completion
September 16, 2021
Last Updated
August 14, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share