NCT04621734

Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle

Completed NA Results posted Last updated 14 August 2023

What this trial tests

NA trial testing AMT BridlePro Device in Feeding Tube Complication in 35 participants. Completed in 16 September 2021.

Timeline

18 February 2020

Primary endpoint
30 April 2021

16 September 2021

Quick facts

Lead sponsor	The University of Texas Health Science Center at San Antonio
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	18 February 2020
Primary completion	30 April 2021
Estimated completion	16 September 2021
Sites	1 location across United States

Drugs / interventions tested

• AMT BridlePro Device
• Adhesive Tape

Conditions studied

• Feeding Tube Complication — all drugs for Feeding Tube Complication →

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

Under 18, any sex, with Feeding Tube Complication. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Tube Dislodgements Per 10 Tube Days. Primary · 10 days

The number of times the tube is dislodged for every 10 days of feeding tubes.

Group	Value	95% CI
Nasal Bridle to Secure Feeding Tube	0.16	0 – 10
Adhesive Tape Use to Secure Feeding Tube	2.11	0 – 10

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nasal Bridle to Secure Feeding Tube

Serious: 0/17 (0%)

Deaths: 0/17

Adhesive Tape Use to Secure Feeding Tube

Serious: 0/18 (0%)

Deaths: 0/18

Other adverse events (1 terms — click to expand)

Reaction	System	Nasal Bridle to Secure Fee…	Adhesive Tape Use to Secur…
Skin Breakdown	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT04621734 adverse events section.

Sponsor's own description

A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Improving retention of pediatric feeding tubes with a nasal bridle: a randomized controlled trial.
   Foster M, Armijo-Garcia V, Gelfond J, Meyer AD. · · 2025 · PMID 40369642 · DOI 10.1186/s13063-025-08867-x