Gravitas Feeding Tube System Placement Validation in Neonates
Study Details
Study Description
Brief Summary
The purpose of this study is to validate 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gravitas FT System
|
Device: Gravitas FT and Gravitas FT Monitor guidance
FT placed with guidance from the Gravitas FT system
|
| Active Comparator: Control
|
Device: Gravitas FT System without placement guidance
SOC placement
|
Outcome Measures
Primary Outcome Measures
- Incidence of device and procedure-related adverse events that occur while the feeding tube is within a subject. The number and type of adverse events will be collected. [1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Infants in the Newborn Intensive Care Unit or on the general medical floor requiring a 5-8 Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that size is appropriate.
-
Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
-
Suitable to start enteral (gastric but not post-pyloric) feeding
-
Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.
-
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.
Exclusion Criteria:
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Known major upper airway malformation (e.g. tracheoesophageal fistula)
-
Known major GI malformation (e.g. malrotation)
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NPO status - neonate expected to remain NPO/NPG for the following 72 hours
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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
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Critically ill, facing imminent death
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Neonate on ECMO
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Deemed unsuitable for enrollment in study by the site principal investigator based on the patients' medical history
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Infant needs an MRI in the immediate future (e.g. 6-12h)
-
Infant needs post-pyloric feeds (distal to stomach)
-
Infant has a basilar skull fracture
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Gravitas Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRD-04-1645-01