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 Overview
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Brief Summary
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Objectives: 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 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 To establish normative pH values for neonates

Detailed Description
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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.

Official Title
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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
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Establish Normative pH Values in Neonates

Intervention / Treatment
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* Device: RightSpot Infant pH Indicator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 24 Weeks
Maximum Age: 40 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: RightSpot Infant pH Indicator|pH indicator|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates |  | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ph, RightSpot Infant, Feeding Tube, RightBio Metrics, placement, Nasogastric Tube, NG, infant