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

Completed

• Conditions: Premature Birth

• Registration Number: NCT06274944
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-06
• Study Start: 2024-02-12
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-23
• Status Verified: 2025-01
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PH reading comparison	baseline	Comparing the accuracy of the novel NG/OG tube placement device pH reading to the standard pH testing method.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States