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New feeding tube tech tested in 100 NICU babies

NCT ID NCT05914064

Knowledge-focused Sponsor: Gravitas Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checks if a new feeding tube system (Gravitas) works safely and correctly in newborns up to 2 years old in the NICU. About 100 infants will get the tube for nutrition, fluids, or medicine. Researchers will watch for any problems while the tube is in place.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 weeks to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants in the Newborn Intensive Care Unit or on the general medical floor requiring a 5-8 Fr NG tube. The desired size of the feeding tube should be determined clinically, and the Gravitas 5-8 Fr Feeding Tube should only be placed if that size is 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 clinically indicated to receive a feeding tube. * If enteral nutrition has already been initiated, the orogastric/nasogastric feeding tube may be replaced with a Gravitas Feeding Tube. * 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. 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 site principal investigator for any other reason * Requirement for post-pyloric feeds (distal to stomach) * Infant has a basilar skull fracture

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasogastric tube

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Lucile Packard (Stanford) Children's Hospital

    Stanford, California, 94303, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • University of Virginia Children's Health

    Charlottesville, Virginia, 22903, United States

  • Women & Infants Hospital, Rhode Island

    Providence, Rhode Island, 02905, United States

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