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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasogastric Tube | Device | Temperature and impedance data will be collected from sensors embedded within the feeding tube wall. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 5 months |
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Infants in the Newborn Intensive Care Unit requiring a 5Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5Fr Feeding Tube should only be placed if that size is appropriate.
Inclusion Criteria:
Exclusion Criteria:
Both neonates on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.
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Neonates in NICU
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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