Gravitas Feeding Tube System Placement Validation in Neonates

Gravitas Medical

Status

Active, not recruiting

Conditions

Nasogastric Tube

Treatments

Device: Gravitas FT and Gravitas FT Monitor 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

100 estimated patients

Sex

All

Ages

Under 2 years 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 2 years post-partum. Can be up to 15 weeks preterm (gestational age ≥ 25 weeks).
Suitable to start or continue gastric enteral feeding, or otherwise clinically indicated to receive a feeding tube.
If enteral nutrition has already been initiated, the orogastric/nasogastric feeding tube may be replaced with a Gravitas 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, esophageal atresia, etc.)
History of gastrectomy or esophagectomy
Expected survival of less than one week
Neonate on ECMO
Deemed unsuitable for enrollment in study based on the judgement of the site principal investigator for any other reason
Requirement for post-pyloric feeds (distal to stomach)
Infant has a basilar skull fracture