Establish Normative pH Values in Neonates
Conditions
Keywords
ph, RightSpot Infant, Feeding Tube, RightBio Metrics, placement, Nasogastric Tube, NG, infant
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.
Interventions
DEVICERightSpot Infant pH Indicator
pH indicator
Sponsors
RightBio Metrics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 40 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Residual amount (ml) at the time of testing | 12 weeks |
| Gestation age at birth | 12 weeks |
| Medications given which effect pH of gastric contents | 12 weeks |
| pH reading from gastric secretions | 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 |
Countries
United States
Outcome results
None listed