Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
NCT02279264 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40
Last updated 2014-10-31
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
Conditions
- Establish Normative pH Values in Neonates
Interventions
- DEVICE
-
RightSpot Infant pH Indicator
pH indicator
Sponsors & Collaborators
-
RightBio Metrics
lead INDUSTRY
Eligibility
- Min Age
- 24 Weeks
- Max Age
- 40 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-09-30
- Primary Completion
- 2014-11-30
Countries
- United States
Study Locations
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