Phase
Condition
N/ATreatment
Gravitas FT and Gravitas FT Monitor guidance
Gravitas FT System without placement guidance
Clinical Study ID
Ages < 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Infants in the Newborn Intensive Care Unit or on the general medical floor requiringa 5-8 Fr NG tube. The desired size of the feeding tube should be determinedclinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that sizeis 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 clinicallyindicated to receive a feeding tube.
If enteral nutrition has already been initiated, the orogastric/nasogastric feedingtube may be replaced with a Gravitas 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, 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 siteprincipal investigator for any other reason
Requirement for post-pyloric feeds (distal to stomach)
Infant has a basilar skull fracture
Study Design
Connect with a study center
Lucile Packard (Stanford) Children's Hospital
Stanford, California 94303
United StatesSite Not Available
Lucile Packard (Stanford) Children's Hospital
Stanford 5398563, California 5332921 94303
United StatesSite Not Available
Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000 31404
United StatesSite Not Available
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
United StatesSite Not Available
Women & Infants Hospital, Rhode Island
Providence 5224151, Rhode Island 5224323 02905
United StatesSite Not Available
University of Virginia Children's Health
Charlottesville, Virginia 22903
United StatesSite Not Available
University of Virginia Children's Health
Charlottesville 4752031, Virginia 6254928 22903
United StatesSite Not Available

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