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 Metrics

Status: Unknown

Conditions: Establish Normative pH Values in Neonates

Treatments: Device: RightSpot Infant pH Indicator

Study type: Observational

Funder types: Industry

Identifiers

NCT02279264

RBM-2014-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 24 to 40 weeks old

Volunteers: No Healthy Volunteers

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