Gravitas Feeding Tube System Placement in Neonates

Completed

• Conditions: Nasogastric Tube
• Interventions: Device: Nasogastric Tube

• Registration Number: NCT05517707
• Lead Sponsor: Gravitas Medical, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2022-11-10
• Primary Completion: 2023-08-29
• Study Completion: 2023-08-29
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Nasogastric tube group	Nasogastric Tube	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.

Primary Outcome Measures

Name	Time	Method
Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.	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.	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.	5 months	The number and type of adverse events will be collected.

Trial Locations

Locations (1)

Lucile Packard Children's Hospital; 🇺🇸 Palo Alto, California, United States