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 Type
OBSERVATIONAL
Enrollment
16
Temperature and impedance data will be collected from sensors embedded within the feeding tube wall.
Lucile Packard Children's Hospital
Palo Alto, California, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 5 months
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