Nasogastric/Orogastric Tube Placement Confirmation in Neo... | NCT06274944

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

NCT06274944

Sponsor

University of Minnesota

Status

Completed

Last Update Posted

Jan 27, 2025Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Premature Birth

Interventions

nasogastric tube placement pH confirmation device

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2024Actual

Primary Completion Date

Jan 21, 2025Actual

Completion Date

Jan 21, 2025Actual

First Submitted Date

Feb 6, 2024

First Submission Date that Met QC Criteria

Feb 15, 2024

First Posted Date

Feb 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2025

Last Update Posted Date

Jan 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nasogastric tube placement pH confirmation device	Device	Each participation will get the contents tested by the novel device and the standard of care procedure.	Infants

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

2 Years

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jonathan Strutt	University of Minnesota	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Minnesota		Minneapolis	Minnesota	55414	United States

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided