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