Gravitas Feeding Tube System Placement Validation in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-27

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasogastric Tube

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Gravitas FT System

Group Type EXPERIMENTAL

Gravitas FT and Gravitas FT Monitor guidance

Intervention Type DEVICE

FT placed with guidance from the Gravitas FT system

Interventions

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Gravitas FT and Gravitas FT Monitor guidance

FT placed with guidance from the Gravitas FT system

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

0 Weeks

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No