ACTIVE_NOT_RECRUITING

Gravitas Feeding Tube System Placement Validation in Neonates

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Conditions

Nasogastric Tube

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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:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_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 2 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age at enrollment: 0 to 2 years post-partum. Can be up to 15 weeks preterm (gestational age ≥ 25 weeks).
  3. * Suitable to start or continue gastric enteral feeding, or otherwise clinically indicated to receive a feeding tube.
  4. * If enteral nutrition has already been initiated, the orogastric/nasogastric feeding tube may be replaced with a Gravitas Feeding Tube.
  5. * 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.
  1. * Known major upper airway malformation (e.g. tracheoesophageal fistula)
  2. * Known major GI malformation (e.g. malrotation, esophageal atresia, etc.)
  3. * History of gastrectomy or esophagectomy
  4. * Expected survival of less than one week
  5. * Neonate on ECMO
  6. * Deemed unsuitable for enrollment in study based on the judgement of the site principal investigator for any other reason
  7. * Requirement for post-pyloric feeds (distal to stomach)
  8. * Infant has a basilar skull fracture

Contacts and Locations

Study Locations (Sites)

Lucile Packard (Stanford) Children's Hospital
Stanford, California, 94303
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Women & Infants Hospital, Rhode Island
Providence, Rhode Island, 02905
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 Date2026-12

Study Record Updates

Study Start Date2023-10-27
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Nasogastric Tube