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

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ClinicalTrials.gov Identifier: NCT02279264
Recruitment Status : Unknown
Verified October 2014 by RightBio Metrics.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Sponsor:
Information provided by (Responsible Party):
RightBio Metrics

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

Condition or disease Intervention/treatment
Establish Normative pH Values in Neonates Device: RightSpot Infant pH Indicator

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 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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 Start Date : September 2014
Estimated Primary Completion Date : November 2014

Intervention Details:
  • Device: RightSpot Infant pH Indicator
    pH indicator
    Other Names:
    • RightBio Metrics
    • RSI001


Primary Outcome Measures :
  1. 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. [ Time Frame: 12 weeks ]
  2. 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) [ Time Frame: 12 weeks ]
  3. 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) [ Time Frame: 12 weeks ]
  4. The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Gestation age at birth [ Time Frame: 12 weeks ]
  2. Adjusted gestational age at the time of testing [ Time Frame: 12 weeks ]
  3. Infants weight at the time of testing [ Time Frame: 12 weeks ]
  4. Time infant last ate [ Time Frame: 12 weeks ]
  5. Residual amount (ml) at the time of testing [ Time Frame: 12 weeks ]
  6. pH reading from gastric secretions [ Time Frame: 12 weeks ]
  7. Medications given which effect pH of gastric contents [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants in the Newborn Intensive Care Unit with an NG Tube
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279264


Locations
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United States, Arizona
Banner Good Samaritan Recruiting
Phoenix, Arizona, United States, 85014
Contact: Gregory Martin, MD    602-280-9629    Gregory_Martin@Pediatrix.com   
Principal Investigator: Gregory Martin, MD, FAAP         
Sponsors and Collaborators
RightBio Metrics

Additional Information:
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Responsible Party: RightBio Metrics
ClinicalTrials.gov Identifier: NCT02279264    
Other Study ID Numbers: RBM-2014-001
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by RightBio Metrics:
ph
RightSpot Infant
Feeding Tube
RightBio Metrics
placement
Nasogastric Tube
NG
infant
Additional relevant MeSH terms:
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Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents