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CompletedNCT06274944Updated Jan 27, 2025

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

An observational study in Premature Birth, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged Up to 2 Years. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
Up to 2 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Premature Birth

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Keywords

  • prematurity
  • nasogastric
  • orogastric
03

In context

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 12 is below the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Infants admitted to the University of Minnesota Masonic Children's Hospital neonatal intensive care unit.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Infants

    Infants admitted to the University of Minnesota Masonic Children's Hospital neonatal intensive care unit.

    Device: nasogastric tube placement pH confirmation device

Interventions

  • Devicenasogastric tube placement pH confirmation device

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

06

What researchers measure

Primary outcomes

  1. PH reading comparison

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

    Time frame: baseline

07

Study locations

1 site
  • University of Minnesota
    Minneapolis, Minnesota 55414, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06274944
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Feb 23, 2024
Start date
Feb 12, 2024
Primary completion
Jan 21, 2025
Completion
Jan 21, 2025
Last update
Jan 27, 2025

Study contacts

Jonathan Strutt
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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