Gravitas Feeding Tube System Placement in Neonates

Nasogastric Tube Clinical Trial

Official title:

Gravitas Feeding Tube System Placement in Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517707
• Other study ID #: CRD-04-1493
• Status: Completed
• Start date: November 10, 2022
• Est. completion date: August 29, 2023

Study information

• Verified date: September 2023
• Source: Gravitas Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Weeks to 18 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Nasogastric Tube

Intervention

Device:
• Nasogastric Tube
Temperature and impedance data will be collected from sensors embedded within the feeding tube wall.

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Gravitas Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of accurate verifications of anatomical locations of the tip of the Gravitas feeding tube.	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.	5 months
Primary	Percentage of accurate removals/dislodgements identified by the Gravitas dislodgement algorithm.	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.	5 months
Primary	Adverse events (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the patient.	The number and type of adverse events will be collected.	5 months