Gravitas Feeding Tube System Placement Validation in Neonates

Not Applicable

Recruiting

• Conditions: Nasogastric Tube
• Interventions: Device: Gravitas FT and Gravitas FT Monitor guidance; Device: Gravitas FT System without placement guidance

• Registration Number: NCT05914064
• Lead Sponsor: Gravitas Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Study Start: 2023-10-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Known major upper airway malformation (e.g. tracheoesophageal fistula)
• Known major GI malformation (e.g. malrotation)
• NPO status - neonate expected to remain NPO/NPG 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gravitas FT System	Gravitas FT and Gravitas FT Monitor guidance	-
Control	Gravitas FT System without placement guidance	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Lucile Packard (Stanford) Children's Hospital; 🇺🇸 Stanford, California, United States

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Virginia Children's Health; 🇺🇸 Charlottesville, Virginia, United States