Evaluating the safety of in-line filters for intravenous therapy in newborns
Central Lines Filtration in Newborns: a Multicenter Randomized Controlled Trial
This study is testing if using special filters during IV therapy can help prevent complications in critically ill newborns in the NICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 736 (estimated) |
| Ages | 1 Hour to 3 Months |
| Sex | All |
| Sponsor | University of Turin, Italy Academic / other |
| Locations | 1 site (Torino, Italia) |
| Trial ID | NCT05537389 on ClinicalTrials.gov |
What this trial studies
This trial aims to assess the effectiveness of in-line filtration in reducing culture-negative inflammatory episodes in infants admitted to neonatal intensive care units (NICU). The study will involve infants requiring prolonged infusion therapy with central venous catheters, comparing outcomes with and without the use of in-line filters. The research seeks to demonstrate that these filters can prevent the infusion of harmful particles, potentially reducing complications associated with intravenous therapy in critically ill newborns.
Who should consider this trial
Good fit: Ideal candidates for this study are infants admitted to NICUs who are expected to require prolonged infusion therapy with central venous catheters.
Not a fit: Patients with peripheral venous catheters or those experiencing inflammatory episodes at the time of enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce infectious complications in newborns receiving intravenous therapy.
How similar studies have performed: While in-line filters have shown benefits in older patients, this specific application in newborns is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients admitted to NICU with at least one central venous catheter Exclusion Criteria: * Patients with peripheral venous catheter, patients with inflammatory episode at the time of enrollment
Where this trial is running
Torino, Italia
- Città della Salute e della Scienza — Torino, Italia, Italy (Recruiting)
Study contacts
- Principal investigator: Elena Maggiora, MD — University of Turin, Italy
- Study coordinator: Francesco Cresi, PhD MD
- Email: incas@cresi.org
- Phone: +390113135781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.