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

RightBio Metrics40 enrolled

Overview

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

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

Conditions

Establish Normative pH Values in Neonates

Interventions

RightSpot Infant pH IndicatorDEVICE

pH indicator

Eligibility

Sex: ALLMin age: 24 WeeksMax age: 40 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Banner Good Samaritan

Phoenix, Arizona, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates

Time frame: 12 weeks

Secondary Outcomes

Gestation age at birth

Time frame: 12 weeks

Adjusted gestational age at the time of testing

Time frame: 12 weeks

Infants weight at the time of testing

Time frame: 12 weeks

Time infant last ate

Time frame: 12 weeks

Residual amount (ml) at the time of testing

Time frame: 12 weeks

pH reading from gastric secretions

Time frame: 12 weeks

Data from ClinicalTrials.gov

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