An observational study in Establish Normative pH Values in Neonates, sponsored by RightBio Metrics. Status unknown at 1 site in United States. Open to participants aged 24 Weeks to 40 Weeks. Per ClinicalTrials.gov, last updated 2014-10-31.
Sponsored by RightBio Metrics · Observational
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.
RightBio Metrics is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Infants in the Newborn Intensive Care Unit with an NG Tube
Exclusion Criteria:
pH indicator
Also known as: RightBio Metrics, RSI001
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.
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks
The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates
Time frame: 12 weeks
Gestation age at birth
Time frame: 12 weeks
Adjusted gestational age at the time of testing
Time frame: 12 weeks
Infants weight at the time of testing
Time frame: 12 weeks
Time infant last ate
Time frame: 12 weeks
Residual amount (ml) at the time of testing
Time frame: 12 weeks
pH reading from gastric secretions
Time frame: 12 weeks
Medications given which effect pH of gastric contents
Time frame: 12 weeks
This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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