Gravitas Feeding Tube System Placement Validation in Neonates

Gravitas Medical

Status

Enrolling

Conditions

Nasogastric Tube

Treatments

Device: Gravitas FT and Gravitas FT Monitor guidance

Device: Gravitas FT System without placement guidance

Study type

Interventional

Funder types

Industry

Identifiers

NCT05914064

CRD-04-1645-01

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

Under 18 weeks old

Volunteers

No Healthy Volunteers

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