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

Status unconfirmed

Conditions studied: Establish Normative pH Values in Neonates

In brief

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

Key facts

Study ID

NCT02279264

Run by

RightBio Metrics

People needed

40

Starts

2014-09-01

Last updated by the study team

2014-10-31

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Banner Good Samaritan — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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