Nasogastric TubeNCT05517707
Gravitas Feeding Tube System Placement in Neonates
An observational study of Nasogastric Tube, run by Gravitas Medical, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to optimize the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications. Read more about this study
- Who is it for?
- Ages 0 to 18 weeksHealthy volunteers can take part
- Conditions the study is for
- Nasogastric Tube
- What is being tested?
- Nasogastric Tube
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2022to 29 Aug 2023
- 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 0 to 18 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates in NICU
Who may be able to join
- Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
- Suitable to start enteral feeding
- Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the NICU. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.
Who cannot join
- Known major upper airway malformation (e.g. tracheoesophageal fistula)
- Known major GI malformation (e.g. malrotation)
- NPO status -neonate expected to remain NPO for the following 72 hours
- Has a medical condition that drastically affects gastric acid-secretion (e.g. Zollinger-Ellison Syndrome, congenital achlorhydria, gastrointestinal perforation/leak/obstruction)
- Has had removal of part of the stomach
- Critically ill, facing imminent death
Show all 10Show fewer
- Neonate on ECMO
- Deemed unsuitable for enrollment in study by the site principal investigator based on the patients' medical history
- Ability to have a legally authorized representative provide informed consent
- Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital
Palo Alto, California, 94304
About this study
The purpose of this study is to optimize the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.
- Conditions
- Nasogastric Tube
- Being tested
- Nasogastric Tube
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasogastric TubeDevice
Temperature and impedance data will be collected from sensors embedded within the feeding tube wall.
| Study group | Role | What they receive |
|---|---|---|
| Nasogastric tube group | Neonates age 0-18 weeks post-partum at enrollment with gestational age > 28 weeks will have the Gravitas Feeding Tube placed using standard technique. Tube placement will be verified by the institution standard of care. Study tubes are to remain in place up to 30 days. Receives: Device: Nasogastric Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.
Data collected during the study will be post processed to refine the Gravitas placement algorithm. The position of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to institutional standard of care.
Measured: 5 months
Percentage of accurate removals/dislodgements identified by the Gravitas dislodgement algorithm.
Data collected during the study will be post processed to refine the Gravitas placement algorithm. The removal/dislodgement of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to actual removal/verification of dislodgement by institutional standard of care.
Measured: 5 months
Adverse events (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the patient.
The number and type of adverse events will be collected.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start10 Nov 2022
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogastric TubeStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gravitas Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517707
- Sponsor's protocol ID
- CRD-04-1493
- Status last verified
- Sep 2023
- First submitted
- 19 Aug 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gravitas Feeding Tube System Placement in Neonates
- ClinicalTrials.gov ID
- NCT05517707
- Acronym / sponsor ID
- CRD-04-1493
- Conditions
- Nasogastric Tube
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gravitas Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Nov 2022 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 26 Aug 2022 (actual)
- 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.
The purpose of this study is to optimize the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness of the Gravitas Feeding Tube in the neonate population for the administration of nutrition, fluids and medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nasogastric tube group | – | Device: Nasogastric TubeNeonates age 0-18 weeks post-partum at enrollment with gestational age > 28 weeks will have the Gravitas Feeding Tube placed using standard technique. Tube placement will be verified by the institution standard of care. Study tubes are to remain in place up to 30 days. |
Who may qualify
- Ages
- 0 to 18 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates in NICU
Key inclusion criteria (3 listed)
- Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
- Suitable to start enteral feeding
- Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the NICU. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.
Key exclusion criteria (10 listed)
- Known major upper airway malformation (e.g. tracheoesophageal fistula)
- Known major GI malformation (e.g. malrotation)
- NPO status -neonate expected to remain NPO for the following 72 hours
- Has a medical condition that drastically affects gastric acid-secretion (e.g. Zollinger-Ellison Syndrome, congenital achlorhydria, gastrointestinal perforation/leak/obstruction)
- Has had removal of part of the stomach
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 |
|---|---|---|
| Nasogastric TubeTemperature and impedance data will be collected from sensors embedded within the feeding tube wall. | Device | Nasogastric tube group |
Primary outcome
Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.
Time frame: 5 months
Data collected during the study will be post processed to refine the Gravitas placement algorithm. The position of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to institutional standard of care.
Percentage of accurate removals/dislodgements identified by the Gravitas dislodgement algorithm.
Time frame: 5 months
Data collected during the study will be post processed to refine the Gravitas placement algorithm. The removal/dislodgement of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to actual removal/verification of dislodgement by institutional standard of care.
Adverse events (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the patient.
Time frame: 5 months
The number and type of adverse events will be collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nasogastric Tube, run by Gravitas Medical, Inc. 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 14 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube. (time frame: 5 months). The study lists 3 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 14 Sep 2023.