Feeding Tube ComplicationNCT04621734
Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
A study testing AMT BridlePro Device and Adhesive Tape in people with Feeding Tube Complication, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Feeding Tube Complication
- What is being tested?
- AMT BridlePro Device and Adhesive Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 16 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Need for nasoenteric feeding
- Admitted to University Hospital
- Age 0-18 years
Who cannot join
- 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
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.
Read the detailed description
The adhesive tape will be the tape available in the unit and will be placed by the nurse or provider at the time of nasoenteric tube placement. The tape will be placed around the tube and secured to the cheek on the side of tube. The tape will be replaced as needed per nursing discretion when soiled or the adhesive properties are failing and this information will be tracked. The AMT BridlePro will be placed by the nurse or provider at the time of nasoenteric tube placement. Placement will use the BridlePro system included in the individual BridlePro packaging. Placement and securement will follow manufacturer recommendations and teaching. The BridlePro encircles the vomer bone of the nasal cavity to secure the tube. Sedation medication may be given per standard of care for nasoenteric tube placement at the discretion of the provider team but no separate or additional sedation medication will be given for securement with adhesive tape or the BridlePro.
- Conditions
- Feeding Tube Complication
- Being tested
- AMT BridlePro Device, Adhesive Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT BridlePro DeviceDevice
Also called Applied Medical Technology (AMT) BridlePro Device
A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
Adhesive TapeDevice
Also called Tape
Adhesive tape used to secure nasoenteric tube
| Study group | Role | What they receive |
|---|---|---|
| Nasal bridle to secure feeding tube | Active comparator | The nasal bridle will be used to secure the nasoenteric feeding tube. Receives: Device: AMT BridlePro Device |
| Adhesive Tape use to secure feeding tube | Placebo comparator | Adhesive tape will be used as standard of care to secure the nasoenteric feeding tube. Receives: Device: Adhesive Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Tube Dislodgements Per 10 Tube Days.
The number of times the tube is dislodged for every 10 days of feeding tubes.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start18 Feb 2020
- Primary completion30 Apr 2021
- Study completion16 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feeding Tube ComplicationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronica Armijo, MD, Principal investigator, University of Texas Health at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621734
- Sponsor's protocol ID
- HSC20190225H
- Status last verified
- Aug 2023
- First submitted
- 3 Nov 2020
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40369642
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Retention of Nasoenteric Feeding Tubes in Pediatric Patients Using a Nasal Bridle
- ClinicalTrials.gov ID
- NCT04621734
- Acronym / sponsor ID
- HSC20190225H
- Conditions
- Feeding Tube Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to compare tube dislodgment rates when a nasoenteric feeding tube is secured with adhesive tape vs the AMT BridlePro device.
Detailed description
The adhesive tape will be the tape available in the unit and will be placed by the nurse or provider at the time of nasoenteric tube placement. The tape will be placed around the tube and secured to the cheek on the side of tube. The tape will be replaced as needed per nursing discretion when soiled or the adhesive properties are failing and this information will be tracked. The AMT BridlePro will be placed by the nurse or provider at the time of nasoenteric tube placement. Placement will use the BridlePro system included in the individual BridlePro packaging. Placement and securement will follow manufacturer recommendations and teaching. The BridlePro encircles the vomer bone of the nasal cavity to secure the tube. Sedation medication may be given per standard of care for nasoenteric tube placement at the discretion of the provider team but no separate or additional sedation medication will be given for securement with adhesive tape or the BridlePro.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal bridle to secure feeding tube | Active comparator | Device: AMT BridlePro DeviceThe nasal bridle will be used to secure the nasoenteric feeding tube. |
| Adhesive Tape use to secure feeding tube | Placebo comparator | Device: Adhesive TapeAdhesive tape will be used as standard of care to secure the nasoenteric feeding tube. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Need for nasoenteric feeding
- Admitted to University Hospital
- Age 0-18 years
Key exclusion criteria (8 listed)
- Facial trauma
- Nasal airway obstructions
- Thrombocytopenia (<100 K/μL)
- s/p septoplasty
- Patients with vomer bone graft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMT BridlePro DeviceAlso: Applied Medical Technology (AMT) BridlePro DeviceA device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube. | Device | Nasal bridle to secure feeding tube |
| Adhesive TapeAlso: TapeAdhesive tape used to secure nasoenteric tube | Device | Adhesive Tape use to secure feeding tube |
Primary outcome
Number of Tube Dislodgements Per 10 Tube Days.
Time frame: 10 days
The number of times the tube is dislodged for every 10 days of feeding tubes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40369642Foster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Armijo, MD principal investigator
University of Texas Health at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMT BridlePro Device and Adhesive Tape in people with Feeding Tube Complication, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Tube Dislodgements Per 10 Tube Days. (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04621734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.