BridgeMD
Prevention study for Pediatric Intestinal Failure
Official title KiteLock 4% EDTA Lock Solution for the Prevention of Occlusions in Children With Intestinal Failure
ClinicalTrials.gov ID: NCT05879835
What this study is testing
- What it's testing
- A multi-site, randomized, 2-arm open-label trial to determine if 4% Tetrasodium (EDTA) catheter lock solution is more effective than heparin lock (standard of care) in preventing central venous catheter occlusions in children with intestinal failure (IF) on total parenteral nutrition (TPN).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 4 to 18
You may be able to join if
- Patients managed by the intestinal rehabilitation program at one of the participating centers.
- Diagnosis of intestinal failure defined as need for PN support for \>60 days in previous 74 days for primary intestinal disease (short bowel...
- Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment.
- Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater.
- Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management
You likely can't join if
- A temporary CVC (jugular or femoral) or peripheral catheter.
- 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...
- Known hypersensitivity, allergy, or reaction to EDTA.
- Pregnancy or nursing mother.
- Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of...
- Severe coagulopathy (platelets \ 1.5).
See the full eligibility criteria
- Patients managed by the intestinal rehabilitation program at one of the participating centers.
- 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).
- Expectation of the treating physician that the patient will require PN for at least 6 months following enrollment.
- Age less than 18 years at diagnosis but greater than 4 weeks chronological age or 40 weeks estimated gestational age, whichever is greater.
- Stable TPN cycling (4 hours off TPN minimum per day) enabling home TPN management
- Presence of a tunneled central venous catheter (CVC), port-a-catheter, or peripherally inserted central catheter (PICC).
- Clinical stability for at least 4 weeks and no acute medical comorbidities.
- A minimum dwell time of 4 consecutive hours daily.
- Care provider willing to provide informed consent to participate in the trial and willing to comply with randomization and study protocol.
- A temporary CVC (jugular or femoral) or peripheral catheter.
- 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).
- Known hypersensitivity, allergy, or reaction to EDTA.
- Pregnancy or nursing mother.
- Participation in another investigational device or drug trial within 30 days prior to enrollment (unless approved by the principal investigators of the trial).
- Severe coagulopathy (platelets \ 1.5).
- Diagnosis of immunodeficiency disorder.
- Unstable medical condition requiring hospital admission
- Received antibiotic therapy for CLABSI within last 14 days.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Fort Worth, Texas, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 4 weeks to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Omaha, Nebraska, United States; New York, New York, United States; Durham, North Carolina, United States; Cincinnati, Ohio, United States; Columbus, Ohio, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.