Gravitas Feeding Tube System Placement Validation in Neonates (NCT05914064) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Gravitas Feeding Tube System Placement Validation in Neonates
United States100 participantsStarted 2023-10-27
Plain-language summary
The purpose of this study is to validate 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.
Who can participate
Age range
0 Weeks – 2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of device and procedure-related adverse events that occur while the feeding tube is within a subject. The number and type of adverse events will be collected.