Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
1 other identifier
observational
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedOctober 31, 2014
October 1, 2014
2 months
September 26, 2014
October 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (7)
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
- +2 more secondary outcomes
Interventions
Eligibility Criteria
Infants in the Newborn Intensive Care Unit with an NG Tube
You may qualify if:
- Infants in the Newborn Intensive Care Unit with an NG Tube
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RightBio Metricslead
Study Sites (1)
Banner Good Samaritan
Phoenix, Arizona, 85014, United States
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2014
First Posted
October 31, 2014
Study Start
September 1, 2014
Primary Completion
November 1, 2014
Last Updated
October 31, 2014
Record last verified: 2014-10