Establish Normative pH Values in NeonatesNCT02279264
Product Validation Study of RightSpot Infant pH Indicator for Rapid Bedside Verification of Proper Nasogastric (NG) Tube Placement in Newborn Intensive Care (NICU) Patients
An observational study of Establish Normative pH Values in Neonates, run by RightBio Metrics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 40 weeks
- Conditions the study is for
- Establish Normative pH Values in Neonates
- What is being tested?
- RightSpot Infant pH Indicator
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants in the Newborn Intensive Care Unit with an NG Tube
Who may be able to join
- Infants in the Newborn Intensive Care Unit with an NG Tube
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Banner Good Samaritan
Phoenix, Arizona, 85014
Gregory Martin, MD, 602-280-9629, Gregory_Martin@Pediatrix.com
Gregory Martin, MD, FAAP
About this study
Objectives:
- 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
- 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
- To establish normative pH values for neonates
Read the 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.
- Being tested
- RightSpot Infant pH Indicator
- Keywords
- ph, RightSpot Infant, Feeding Tube, RightBio Metrics, placement, Nasogastric Tube, NG, infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RightSpot Infant pH IndicatorDevice
Also called RightBio Metrics, RSI001
pH indicator
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 12 weeks
The gastric pH measurements will be collected and analyzed to determine the normative pH values for neonates
Measured: 12 weeks
Secondary outcomes (7)
Gestation age at birth
Measured: 12 weeks
Adjusted gestational age at the time of testing
Measured: 12 weeks
Infants weight at the time of testing
Measured: 12 weeks
Time infant last ate
Measured: 12 weeks
Residual amount (ml) at the time of testing
Measured: 12 weeks
pH reading from gastric secretions
Measured: 12 weeks
Medications given which effect pH of gastric contents
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Establish Normative pH Values in NeonatesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RightBio Metrics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279264
- Sponsor's protocol ID
- RBM-2014-001
- Status last verified
- Oct 2014
- First submitted
- 26 Sep 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02279264
- Acronym / sponsor ID
- RBM-2014-001
- Keywords
- ph, RightSpot Infant, Feeding Tube, RightBio Metrics, placement, Nasogastric Tube, NG, infant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- RightBio MetricsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- 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
- 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
- To establish normative pH values for neonates
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants in the Newborn Intensive Care Unit with an NG Tube
Key inclusion criteria (1 listed)
- Infants in the Newborn Intensive Care Unit with an NG Tube
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RightSpot Infant pH IndicatorAlso: RightBio Metrics, RSI001pH indicator | Device | – |
Primary outcome
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
7 secondary outcomes
Gestation age at birth
Time frame: 12 weeks
Adjusted gestational age at the time of testing
Time frame: 12 weeks
Infants weight at the time of testing
Time frame: 12 weeks
Time infant last ate
Time frame: 12 weeks
Residual amount (ml) at the time of testing
Time frame: 12 weeks
pH reading from gastric secretions
Time frame: 12 weeks
Medications given which effect pH of gastric contents
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Establish Normative pH Values in Neonates, run by RightBio Metrics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.