Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients

October 28, 2014 updated by: RightBio Metrics

Objectives:

  1. To validate the accuracy of pH measurements of gastric fluid by comparing the readings from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor
  2. To determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG tube prior to feedings
  3. To establish normative pH values for neonates

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

RightBio Metrics has developed an indicator that rapidly checks gastric pH by aspirating gastric contents into the indicator through a nasogastric (NG) or orogastric (OG), causing a color change on the indicator. The color change represents various pH levels. Most Newborn Intensive Care Units require that NG/OG placement be confirmed after initial insertion and prior to any use. The purpose of this study is to validate the accuracy of pH measurement of gastric fluid by comparing the reading from the RightSpot Infant pH Indicator to a standard clinically approved pH monitor, and to determine what percentage of time the RightSpot Infant pH Indicator could have been used to determine the proper placement of the NG/OG tube prior to use. The gastric pH measurements will be analyzed to determine the normative pH values for neonates.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Recruiting
        • Banner Good Samaritan
        • Contact:
        • Principal Investigator:
          • Gregory Martin, MD, FAAP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Infants in the Newborn Intensive Care Unit with an NG Tube

Description

Inclusion Criteria:

  • Infants in the Newborn Intensive Care Unit with an NG Tube

Exclusion Criteria:

  • Infants with congenital or genetic abnormalities
  • Infants with gastroschesis
  • Infants with upper airway abnormalities
  • Infants receiving any supplement or medication know to alter pH gastric contents
  • Infants receiving Enfamil liquid human milk fortification
  • Infant who are NPO status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the gastric pH measurement obtained from the RightSpot Indicator to the gastric pH measurement obtained from an approved pH monitor to determine the agreement and accuracy of the two modes of measurements.
Time Frame: 12 weeks
12 weeks
To determine the percentage of samples obtained by the RightSpot pH Indicator that could have been used to assist in determining proper placement of the NG tube prior to use. (% of collected samples vs. uncollected)
Time Frame: 12 weeks
12 weeks
To determine the percentage of samples obtained by the RightSpot pH Indicator that could have been used in determining proper placement of the NG tube prior to use.(% of sample accuracy)
Time Frame: 12 weeks
12 weeks
The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Gestation age at birth
Time Frame: 12 weeks
12 weeks
Adjusted gestational age at the time of testing
Time Frame: 12 weeks
12 weeks
Infants weight at the time of testing
Time Frame: 12 weeks
12 weeks
Time infant last ate
Time Frame: 12 weeks
12 weeks
Residual amount (ml) at the time of testing
Time Frame: 12 weeks
12 weeks
pH reading from gastric secretions
Time Frame: 12 weeks
12 weeks
Medications given which effect pH of gastric contents
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RightBio Metrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

October 28, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 28, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RBM-2014-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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