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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Brief Summary

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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

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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.

Conditions

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Establish Normative pH Values in Neonates

Keywords

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ph RightSpot Infant Feeding Tube RightBio Metrics placement Nasogastric Tube NG infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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RightSpot Infant pH Indicator

pH indicator

Intervention Type DEVICE

Other Intervention Names

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RightBio Metrics RSI001

Eligibility Criteria

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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

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner Good Samaritan

Phoenix, Arizona, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Gregory Martin, MD

Role: primary

Other Identifiers

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RBM-2014-001

Identifier Type: -

Identifier Source: org_study_id