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The Safety Evaluation of Silver Alginate (Algidex™) Dressing in Very Low Birth Weight (VLBW) Infants

Prematurity Clinical Trial

Clinical Trial Summary

The purpose of this study is to test the safety of silver alginate (Algidex™) dressing in VLBW infants in preparation for a large efficacy trial.

Clinical Trial Description

We are conducting a pilot randomized controlled trial in VLBW infants to evaluate the safety of silver alginate (Algidex™) dressing compared to standard catheter care. Following parental consent, infants are randomized to receive silver alginate or standard of care dressing. Infants with birth weights less than 1,500 grams admitted to Baylor University Medical Center (BUMC) NICU with any of the following lines are eligible for inclusion into this study up to 72 hours after birth: umbilical arterial line (UAL), umbilical venous line (UVL), peripheral arterial line (PAL), peripheral long line (PLL), and central venous line (CVL). Safety is assessed by measuring silver levels and monitoring for cutaneous reactions. Dressings are changed every seven days. Silver levels are drawn on study days 1, 7, and 28. Blood culture results are used to compare infection rates between the two groups. Patient demographics and clinical conditions are recorded. Results will be analyzed based on intention to treat. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00593684
Study type Interventional
Source Baylor Research Institute
Contact
Status Completed
Phase N/A
Start date April 2006
Completion date December 2007
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