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New catheter lock may cut blockages in kids on long-term nutrition

NCT ID NCT05879835

Disease control Sponsor: SterileCare Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests if a 4% tetrasodium EDTA solution is better than the standard heparin lock at preventing central line blockages in children with intestinal failure who need long-term nutrition through a vein. About 124 children from multiple hospitals will take part. The goal is to reduce the need for extra procedures to fix blocked catheters and to see if it also lowers infection rates.

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 124 people

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

Started

Jun 2024

Expected to finish

Jun 2027

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

4 weeks to 18 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: 1. Patients managed by the intestinal rehabilitation program at one of the participating centers. 2. Diagnosis of intestinal failure defined as need for PN support for \>60 days in previous 74 days for primary intestinal disease (short bowel syndrome, primary motility disorder, mucosal enteropathy). 3. Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment. 4. Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater. 5. Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management 6. Presence of a tunneled central venous catheter (CVC), port-a-catheter, or peripherally inserted central catheter (PICC). 7. Clinical stability for at least 4 weeks and no acute medical comorbidities. 8. A minimum dwell time of 4 consecutive hours daily. 9. Care provider willing to provide informed consent to participate in the trial and willing to comply with randomization and study protocol. Exclusion Criteria: 1. A temporary CVC (jugular or femoral) or peripheral catheter. 2. Patients receiving long-term PN, but not due to a primary intestinal disorder (i.e., oncology patients or premature neonates on PN due to intestinal immaturity). 3. Known hypersensitivity, allergy, or reaction to EDTA. 4. Pregnancy or nursing mother. 5. Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of the trial). 6. Severe coagulopathy (platelets \<50,000, or INR \> 1.5). 7. Diagnosis of immunodeficiency disorder. 8. Unstable medical condition requiring hospital admission 9. Received antibiotic therapy for CLABSI within last 14 days.

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Conditions

The condition(s) this trial relates to.

chronic intestinal failure Hyperphagia Intestinal Failure

As listed by the trial registrant

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

Pediatric intestinal failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Cook Children's Health Care System

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nyph/Cumc

    RECRUITING

    New York, New York, 10032, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • University of Nebraska Medical Center

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68198, United States

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