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Objectives:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RightSpot Infant pH Indicator | Device | pH indicator |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Infants in the Newborn Intensive Care Unit with an NG Tube
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Good Samaritan | Recruiting | Phoenix | Arizona | 85014 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| 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 |