Gravitas Feeding Tube System Placement in Neonates

NCT05517707 | Completed DMC FDA Device

• 1 other identifier: CRD-04-1493
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasogastric Tube

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

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.

Device: Nasogastric Tube

Interventions

Nasogastric Tube DEVICE

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

Nasogastric tube group

Eligibility Criteria

• Age: 0 Weeks - 18 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates in NICU

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gravitas Medical, Inc.: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 26, 2022
• Study Start: November 10, 2022
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)