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Intravenous Neonatal Central Access Safety Trial

Study acronym: INCAS
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Jun 30, 2026 to Sep 7, 2026
    • Enrollment target: estimated 736 to confirmed 768
    • Study description expanded, about 7 words
    • Site details revised
    • Publications: details revised at 9 of 9 entries
    • Eligibility criteria expanded, about 2 words
  2. Re-verified, no change to tracked fieldsv5
  3. Primary and study completion dates: Oct 1, 2024 to Jun 30, 2026v4
  4. Primary completion date: Oct 1, 2023 to Oct 1, 2024
    • Enrollment target: 800 to 736
    • Study description expanded, about 165 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2022 to Jan 1, 2023
    • Study sites: 0 to 1
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU). In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in neonates, remain to be demonstrated. In-line filters in the intravenous administration sets prevent the infusion of particles, which may reduce infectious complications.
Trial Details
NCT Number NCT05537389
Lead Sponsor University of Turin, Italy
Collaborators: Pall Corporation
Conditions
(from sponsor)		 Newborn Complication, Catheter Complications
Enrollment 768 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov