Clinical trial NCT02279264: Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
Official title: Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Establish Normative pH Values in Neonates
Keywords: ph
RightSpot Infant
Feeding Tube
RightBio Metrics
placement
Nasogastric Tube
NG
infant
Lead sponsor: RightBio Metrics
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants in the Newborn Intensive Care Unit with an NG Tube

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
measure: The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates
timeFrame: 12 weeks
Secondary outcomes:
measure: Gestation age at birth
timeFrame: 12 weeks
measure: Adjusted gestational age at the time of testing
timeFrame: 12 weeks
measure: Infants weight at the time of testing
timeFrame: 12 weeks
measure: Time infant last ate
timeFrame: 12 weeks
measure: Residual amount (ml) at the time of testing
timeFrame: 12 weeks
measure: pH reading from gastric secretions
timeFrame: 12 weeks
measure: Medications given which effect pH of gastric contents
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Good Samaritan
state: Arizona
Study officials:
References: