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

This study has been completed.
Sponsor:
Collaborator:
DeRoyal
Information provided by:
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT00593684
First received: January 4, 2008
Last updated: January 14, 2008
Last verified: January 2008
History of Changes
  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.


Condition Intervention
Prematurity
Very Low Birth Weight
 Device: Silver Alginate (Algidex™)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • The primary outcome of this study is to assess the safety of silver alginate(Algidex™) dressing in VLBW infants [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary outcome of this study is to determine the effect of silver alginate dressing use on central line infection rates. [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2005
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593684

Locations
United States, Texas
Baylor University Medical Center - Women and Children's Services
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Baylor Research Institute
DeRoyal
Investigators
Principal Investigator: Asif Khattak, M.D. Baylor Health Care System
  More Information

No publications provided

Responsible Party: Asif Khattak, Baylor Research Institute
ClinicalTrials.gov Identifier: NCT00593684     History of Changes
Other Study ID Numbers: Baylor IRB #005-206, 0000
Study First Received: January 4, 2008
Last Updated: January 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Research Institute:
neonate
central lines
very low birth weight
silver alginate

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms
Alginic acid
Hemostatics
Coagulants
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013