Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
16 participants
OBSERVATIONAL
2022-11-10
2023-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nasogastric tube group
Neonates age 0-18 weeks post-partum at enrollment with gestational age \> 28 weeks will have the Gravitas Feeding Tube placed using standard technique. Tube placement will be verified by the institution standard of care. Study tubes are to remain in place up to 30 days.
Nasogastric Tube
Temperature and impedance data will be collected from sensors embedded within the feeding tube wall.
Interventions
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Nasogastric Tube
Temperature and impedance data will be collected from sensors embedded within the feeding tube wall.
Eligibility Criteria
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Inclusion Criteria
* Suitable to start enteral feeding
* Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the NICU. If enteral nutrition has already been initiated, indicated for replacement of an orogastric/nasogastric feeding tube.
Exclusion Criteria
* Known major GI malformation (e.g. malrotation)
* NPO status -neonate expected to remain NPO 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
* 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.
0 Weeks
18 Weeks
ALL
Yes
Sponsors
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Gravitas Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Lucile Packard Children's Hospital
Palo Alto, California, United States
Countries
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Other Identifiers
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CRD-04-1493
Identifier Type: -
Identifier Source: org_study_id
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