Gravitas Feeding Tube System Placement Validation in Neonates

Nasogastric Tube Clinical Trial

Official title:

Gravitas Feeding Tube System Placement Validation in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914064
• Other study ID #: CRD-04-1645-01
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Gravitas Medical, Inc.
• Contact: Carleen Tabari
• Phone: 6505166508
• Email: ctabari[@]gravitasmedinc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Weeks to 18 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Nasogastric Tube

Intervention

Device:
• Gravitas FT and Gravitas FT Monitor guidance
FT placed with guidance from the Gravitas FT system
• Gravitas FT System without placement guidance
SOC placement

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Virginia Children's Health	Charlottesville	Virginia
United States	Lucile Packard (Stanford) Children's Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Gravitas Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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