Validation of a Feeding Tube System for Neonates

Gravitas Feeding Tube System Placement Validation in Neonates

This study is testing a new feeding tube system to see if it can safely and effectively help newborns in the NICU get the nutrition and medications they need.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 0 Weeks to 18 Weeks
• Sex: All
• Sponsor: Gravitas Medical, Inc. (Industry-sponsored)
• Locations: 3 sites (Stanford, California and 2 other locations)
• Trial ID: NCT05914064 on ClinicalTrials.gov

What this trial studies

This study aims to validate the Gravitas Feeding Tube System Placement Algorithm specifically for neonates in the Newborn Intensive Care Unit (NICU). It will assess the safety and effectiveness of the Gravitas Feeding Tube for administering nutrition, fluids, and medications to this vulnerable population. The study involves using the Gravitas FT and Gravitas FT Monitor for guidance, as well as the system without placement guidance. The goal is to ensure that the feeding tube is placed correctly and safely in infants requiring enteral feeding.

Who should consider this trial

Good fit: Ideal candidates include infants in the NICU or on the general medical floor who require a 5-8 Fr nasogastric tube and are suitable for enteral feeding.

Not a fit: Patients with known major upper airway malformations or significant gastrointestinal malformations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and accuracy of feeding tube placements in neonates, enhancing their nutritional care.

How similar studies have performed: While this specific approach is novel, similar studies focusing on feeding tube placement in neonates have shown varying degrees of success.

Eligibility criteria

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

Where this trial is running

Stanford, California and 2 other locations

• Lucile Packard (Stanford) Children's Hospital — Stanford, California, United States (Recruiting)
• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Virginia Children's Health — Charlottesville, Virginia, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Carleen Tabari

Conditions Nasogastric Tube