Status:

UNKNOWN

Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients

Lead Sponsor:

RightBio Metrics

Conditions:

Establish Normative pH Values in Neonates

Eligibility:

All Genders

24-40 years

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 determi...

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 th...

Eligibility Criteria

Inclusion

  • Infants in the Newborn Intensive Care Unit with an NG Tube

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2014

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT02279264

Start Date

September 1 2014

Last Update

October 31 2014

Active Locations (1)

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Phoenix, Arizona, United States, 85014