Gravitas Feeding Tube System Placement in Neonates

The purpose of this study is to optimize 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.

Completed

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Key information

Conditions

Nasogastric Tube

Age range

0 week–18 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Infants in the Newborn Intensive Care Unit requiring a 5Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5Fr Feeding Tube should only be placed if that size is appropriate.

Inclusion criteria

Age at enrollment: 0 to 18 weeks post-partum. Can be up to 12 weeks preterm (gestational age ≥ 28 weeks).
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 upper airway malformation (e.g. tracheoesophageal fistula)
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.

Treatment and study plan

Nasogastric tube

Device

Temperature and impedance data will be collected from sensors embedded within the feeding tube wall.

Primary outcomes

Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.

Time frame: 5 months

Data collected during the study will be post processed to refine the Gravitas placement algorithm. The position of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to institutional standard of care.
Percentage of accurate removals/dislodgements identified by the Gravitas dislodgement algorithm.

Time frame: 5 months

Data collected during the study will be post processed to refine the Gravitas placement algorithm. The removal/dislodgement of the feeding tube tip as processed by the Gravitas placement algorithm will be compared to actual removal/verification of dislodgement by institutional standard of care.
Adverse events (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the patient.

Time frame: 5 months

The number and type of adverse events will be collected.

Sponsors and collaborators

Lead sponsor

Gravitas Medical, Inc.

Industry

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Aug 26, 2022
Registry last updated: Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed