RECRUITING

Gravitas Feeding Tube System Placement Validation in Neonates

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Gravitas Feeding Tube System Placement Validation in Neonates

Quick Facts

Study Start:2023-10-27

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05914064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Weeks to 18 Weeks

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Carleen Tabari

CONTACT

6505166508

ctabari@gravitasmedinc.com

Study Locations (Sites)

Lucile Packard (Stanford) Children's Hospital

Stanford, California, 94303

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

University of Virginia Children's Health

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Gravitas Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-27

Study Completion Date2024-12

Study Record Updates

Study Start Date2023-10-27

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Nasogastric Tube