Last updated: February 23, 2024
Sponsor: Gravitas Medical, Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
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
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 StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
University of Virginia Children's Health
Charlottesville, Virginia 22903
United StatesSite Not Available
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