Prematurity, Very Low Birth Weight
Conditions
Keywords
neonate, central lines, very low birth weight, silver alginate
Brief 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.
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.
Interventions
DEVICESilver Alginate
This is a sterile patch of polyurethane foam coated with silver alginate and maltodextrin matrix that is impregnated with 141 mg of ionic silver per 100 cm2.
Sponsors
DeRoyal Industries, Inc.
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 72 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Silver Concentration at 1 Day | 1 Day (first 24 hours from enrollment) | Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique. |
| Serum Silver Concentration at 7 Days | 7 Days from enrollment | Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique. |
| Serum Silver Concentrate at 28 Days | 28 Days from enrollment | Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate | infection per 1,000 Line Days | Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days. |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled at the Baylor University Medical Center Neonatal Intensive Care Unit between April 2006 and December 2007.
Pre-assignment details
Enrollment and group assignment occurred concurrently.
Participants by arm
| Arm | Count |
|---|---|
| Algidex Patch | 25 |
| Control Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite). | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
Baseline characteristics
| Characteristic | Algidex Patch | Control | Total |
|---|---|---|---|
| Age, Continuous | 27.3 weeks STANDARD_DEVIATION 2.03 | 27.2 weeks STANDARD_DEVIATION 1.85 | 27.25 weeks STANDARD_DEVIATION 2 |
| Average Line Days | 17.95 line days STANDARD_DEVIATION 8.8 | 19 line days STANDARD_DEVIATION 9.9 | 18.5 line days STANDARD_DEVIATION 9.35 |
| Birth Weight (grams) | 955 Grams STANDARD_DEVIATION 250 | 913 Grams STANDARD_DEVIATION 209 | 934 Grams STANDARD_DEVIATION 229 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) White | 3 Participants | 15 Participants | 18 Participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 2 / 25 | 4 / 25 |
Outcome results
Primary
Serum Silver Concentrate at 28 Days
Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine results at 28 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique.
Time frame: 28 Days from enrollment
Population: two subjects died in the treatment group; one subject died in the control group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Algidex Patch | Serum Silver Concentrate at 28 Days | 3.19 ng ml -1 | Standard Deviation 3.23 |
| Control | Serum Silver Concentrate at 28 Days | 0.21 ng ml -1 | Standard Deviation 0.07 |
Primary
Serum Silver Concentration at 1 Day
Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we are examining the results of first day, or 24 hours from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique.
Time frame: 1 Day (first 24 hours from enrollment)
Population: Study design included intent-to-treat for data collection and intention to stop if signs of toxicities or adverse effects were noted.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Algidex Patch | Serum Silver Concentration at 1 Day | 7.6 ng ml -1 | Standard Deviation 20.93 |
| Control | Serum Silver Concentration at 1 Day | 0.22 ng ml -1 | Standard Deviation 0.09 |
Primary
Serum Silver Concentration at 7 Days
Serum silver concentrations were obtained from both groups on study days 1, 7, and 28. Study day 1 was defined as the 24 hour period in which participants enrolled in the study. Here we examine the results at 7 days from enrollment. Silver samples were analyzed using a dual inductively coupled plasma -mass spectrometry methodology. Accepted reference values for non-exposure silver concentrations are defined as \<15 ng ml -1 with standard Mayo Clinic reference technique.
Time frame: 7 Days from enrollment
Population: One subject in each group died
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Algidex Patch | Serum Silver Concentration at 7 Days | 4.79 ng ml -1 | Standard Deviation 4.37 |
| Control | Serum Silver Concentration at 7 Days | 0.23 ng ml -1 | Standard Deviation 0.14 |
Secondary
Infection Rate
Infection was defined as recovery of a bacterial pathogen or fungus from any single blood culture. Infection rate was defined as Infections/1000 line days.
Time frame: infection per 1,000 Line Days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Algidex Patch | Infection Rate | 6.69 Infection per 1,000 line days |
| Control | Infection Rate | 12.34 Infection per 1,000 line days |