Recruiting

Observational Study

Sponsor:

RightBio Metrics

Code:

NCT02279264

Conditions

Establish Normative pH Values in Neonates

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

RightSpot Infant pH Indicator

Study Details

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

Conditions

Establish Normative pH Values in Neonates

Study ID

NCT02279264

Start date

Sep, 2014

Status verified date

Oct, 2014

Primary completion date

Nov, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Interventions

RightSpot Infant pH Indicator

pH indicator

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Banner Good Samaritan

Recruiting

Phoenix, Arizona, United States, 85014

Contacts

Gregory Martin, MD

602-280-9629Gregory_Martin@Pediatrix.com

Principal Investigator:

Gregory Martin, MD, FAAP

More Information

Sponsor

RightBio Metrics

Last update posted

Oct 31, 2014

Last verified

Oct, 2014

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by RightBio Metrics on 2014-10-31.