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NCT06274944 Clinical Trial

Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study

Premature Birth Clinical Trial

Official title:
Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06274944
Other study ID # PEDS-2023-31694
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 12, 2024
Est. completion date January 31, 2025

Study information
Verified date February 2024
Source University of Minnesota
Contact Brittany Faanes
Phone 612-625-5929
Email grego318@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is looking at using a self-contained pH device that will assist in confirming placement of a nasogastric or orogastric tube placed in the stomach of hospitalized infants.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date January 31, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility Inclusion Criteria: - All patients admitted to the NICU at the University of Minnesota Masonic Children's Hospital, Minneapolis, MN requiring placement of an NG/OG tube are eligible to enroll. Exclusion Criteria: - Participant deemed unsuitable for study by the treating provider. Participants who are on the following medications: proton-pump inhibitor (PPI's) or H2 blockers within one week prior to the device assessment.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• nasogastric tube placement pH confirmation device
Each participation will get the contents tested by the novel device and the standard of care procedure.

Locations
Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary PH reading comparison Comparing the accuracy of the novel NG/OG tube placement device pH reading to the standard pH testing method. baseline
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