Gravitas Feeding Tube System Placement in Neonates

Gravitas Medical

Status: Completed

Conditions: Nasogastric Tube

Treatments: Device: Nasogastric Tube

Study type: Observational

Funder types: Industry

Identifiers

NCT05517707

CRD-04-1493

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: Under 18 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Infants in the Newborn Intensive Care Unit requiring a 5Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5Fr Feeding Tube should only be placed if that size is appropriate.

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.

Trial design

16 participants in 1 patient group

Nasogastric tube group

Description:

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.

Treatment:

Device: Nasogastric Tube