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

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

nasogastric tube placement pH confirmation device

Device

Each participation will get the contents tested by the novel device and the standard of care procedure.

Primary outcomes

PH reading comparison

Time frame: baseline

Comparing the accuracy of the novel NG/OG tube placement device pH reading to the standard pH testing method.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 23, 2024
Registry last updated: Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed