Central Line Bloodstream Infections Clinical Trial
Official title:
The Efficacy of Silver Alginate (Algidex®) Dressing in Reducing Central Line Infections in Very Low Birth Weight (VLBW) Infants: A Multicenter Collaborative Randomized Controlled Trial.
The purpose of this study is to determine whether silver alginate (Algidex) patch is effective in the prevention of central line infections in very low birth weight infants.
With rapid technological advancement, the increased use of vascular catheters has not only
improved patient care strategies, but also contributed to the risk of infection.
Unfortunately, catheter related blood stream infections still remain one of the major causes
of morbidity in VLBW infants. In the United States, approximately 850,000 infections are
attributed to catheters annually, occurring primarily in intensive care unit patients. The
National Institute of Child Health and Human Development stated that 20% of infants less
than 1500 grams will have at least one positive blood culture delaying their stay in the
neonatal intensive care unit (NICU).
One approach to reducing the incidence of infection could be utilizing the antimicrobial
properties of silver. Silver alginate has been proven safe and beneficial in the adult
population in preventing catheter related infections. Studies done in mice and rats suggest
acute toxicity occurring when the animals were given 23 mg of silver acetate/kg of body
weight and chronic toxicity noticed when animals were given 1.5 mg/kg/day (5) Chronic
toxicity in humans was shown with ingestion of 13 mg/kg/day (3) In our recently concluded
pilot randomized controlled trial done in VLBW infants, safety of silver alginate was
demonstrated by lack of skin reactions to the patches and mild increase in serum silver
level ( Khattak et al; Pediatrics research March 2008, clinicaltrials.gov id: NCT00593684 ).
However, there is no clinical evidence of efficacy in VLBW neonatal population. Based on the
data from our pilot safety study, we hypothesize that using silver alginate dressing in this
population will be efficacious in the prevention of blood stream infections. Although
initial studies suggest that absorbed silver is not in a range toxic to human infants, we
will continue to monitor silver levels in certain infants.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention