Nasogastric Tube
Conditions
Brief 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.
Interventions
DEVICEGravitas FT and Gravitas FT Monitor guidance
FT placed with guidance from the Gravitas FT system
Sponsors
Gravitas Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed