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

• Conditions: Establish Normative pH Values in Neonates

• Registration Number: NCT02279264
• Lead Sponsor: RightBio Metrics

Brief Summary

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

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 Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-26
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-28
• Last Update Submitted: 2014-10-28
• Study First Posted: 2014-10-31
• Last Update Posted: 2014-10-31
• Primary Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)	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)	12 weeks
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.	12 weeks
The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates	12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Banner Good Samaritan; 🇺🇸 Phoenix, Arizona, United States