Gravitas Feeding Tube System Placement Validation in Neonates

Last updated: February 23, 2024
Sponsor: Gravitas Medical, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Gravitas FT and Gravitas FT Monitor guidance

Gravitas FT System without placement guidance

Clinical Study ID

NCT05914064
CRD-04-1645-01
  • Ages < 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 isappropriate.
  • 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 morethan 6 hours. If enteral nutrition has already been initiated, indicated forreplacement of an orogastric/nasogastric feeding tube.
  • Ability to have a legally authorized representative provide informed consent Bothneonates on a ventilator (non-invasive or invasive ventilation) or not requiring aventilator are eligible for this study.

Exclusion

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, gastrointestinalperforation/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 onthe 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

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: Gravitas FT and Gravitas FT Monitor guidance
Phase:
Study Start date:
October 27, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Lucile Packard (Stanford) Children's Hospital

    Stanford, California 94303
    United States

    Active - Recruiting

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • University of Virginia Children's Health

    Charlottesville, Virginia 22903
    United States

    Site Not Available

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