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

Completed

• Conditions: Premature Birth
• Interventions: Device: nasogastric tube placement pH confirmation device

• 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

Arm && Interventions

Group	Intervention	Description
Infants	nasogastric tube placement pH confirmation device	Infants admitted to the University of Minnesota Masonic Children's Hospital neonatal intensive care unit.

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