Expired Study
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Dallas, Texas 75204


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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). Exclusion Criteria: - N/A


NCT ID:

NCT00593684


Primary Contact:

Principal Investigator
Furgan Moin, M.D.
Baylor Health Care System


Backup Contact:

N/A


Location Contact:

Dallas, Texas 75204
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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