NCT06274944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

February 6, 2024

Last Update Submit

January 23, 2025

Conditions

Premature Birth

Keywords

prematuritynasogastricorogastric

Outcome Measures

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.

    baseline

Study Arms (1)

Infants

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

Device: nasogastric tube placement pH confirmation device

Interventions

nasogastric tube placement pH confirmation deviceDEVICE

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

Infants

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jonathan Strutt

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 23, 2024

Study Start

February 12, 2024

Primary Completion

January 21, 2025

Study Completion

January 21, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

US(1)