Trial Outcomes & Findings for Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle (NCT NCT04621734)
NCT ID: NCT04621734
Last Updated: 2023-08-14
Results Overview
The number of times the tube is dislodged for every 10 days of feeding tubes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
10 days
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
Nasal Bridle to Secure Feeding Tube
The nasal bridle will be used to secure the nasoenteric feeding tube.
AMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
|
Adhesive Tape Use to Secure Feeding Tube
Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.
Adhesive Tape: Adhesive tape used to secure nasoenteric tube
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
18
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
Baseline characteristics by cohort
| Measure |
Nasal Bridle to Secure Feeding Tube
n=17 Participants
The nasal bridle will be used to secure the nasoenteric feeding tube.
AMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
|
Adhesive Tape Use to Secure Feeding Tube
n=18 Participants
Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.
Adhesive Tape: Adhesive tape used to secure nasoenteric tube
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
6.5 years
n=93 Participants
|
9.1 years
n=4 Participants
|
7.8 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
18 participants
n=4 Participants
|
35 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 10 daysThe number of times the tube is dislodged for every 10 days of feeding tubes.
Outcome measures
| Measure |
Nasal Bridle to Secure Feeding Tube
n=16 Participants
The nasal bridle will be used to secure the nasoenteric feeding tube.
AMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
|
Adhesive Tape Use to Secure Feeding Tube
n=17 Participants
Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.
Adhesive Tape: Adhesive tape used to secure nasoenteric tube
|
|---|---|---|
|
Number of Tube Dislodgements Per 10 Tube Days.
|
0.16 Dislodgements
Interval 0.0 to 10.0
|
2.11 Dislodgements
Interval 0.0 to 10.0
|
Adverse Events
Nasal Bridle to Secure Feeding Tube
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Adhesive Tape Use to Secure Feeding Tube
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nasal Bridle to Secure Feeding Tube
n=17 participants at risk
The nasal bridle will be used to secure the nasoenteric feeding tube.
AMT BridlePro Device: A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
|
Adhesive Tape Use to Secure Feeding Tube
n=18 participants at risk
Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube.
Adhesive Tape: Adhesive tape used to secure nasoenteric tube
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Breakdown
|
5.9%
1/17 • Number of events 1 • 30 days
|
22.2%
4/18 • Number of events 4 • 30 days
|
Additional Information
Dr. Veronica Armijo-Garcia
University of Texas Health Science Center at San Antonio
Phone: 210-274-8969
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place