NCT00964093

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2014

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2015

Completed
Last Updated

March 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5.8 years

First QC Date

August 21, 2009

Last Update Submit

March 19, 2026

Conditions

Central Line Bloodstream Infections

Keywords

prematureinfectioncentral linevery low birth weightsilver alginateAlgidexneonatalNICU

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this trial is to assess the efficacy of silver alginate dressing in reducing central line infections in VLBW infants

    2 years

Secondary Outcomes (1)

  • The secondary objectives are to compare mortality and total days of hospitalization between the groups. Safety will be assessed by obtaining silver levels, skin integrity, and adverse events related to the dressing.

    2 years

Study Arms (1)

No intervention

NO INTERVENTION
Device: Silver Alginate

Interventions

Silver AlginateDEVICE

(Algidex ™)

No intervention

Eligibility Criteria

Age1 Day - 3 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • umbilical arterial line (UAL)
  • umbilical venous line (UVL)
  • peripheral arterial line (PAL)
  • peripheral long line (PLL)
  • central venous line (CVL)
  • Each eligible subject will be randomized to receive either standard of care or silver alginate dressing. Dressings will be changed every 7 days in accordance to current facility protocols.

You may not qualify if:

  • \. Any infant born with a lethal abnormality or who has received topical Silver therapy will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor University Medical Center - Women and Children's Services

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Premature BirthInfections

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Asif Khattak, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

  • David M Kanter, MD

    St. Mary's Medical Center, West Palm Beach, FL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2009

First Posted

August 24, 2009

Study Start

November 23, 2008

Primary Completion

August 25, 2014

Study Completion

August 20, 2015

Last Updated

March 23, 2026

Record last verified: 2026-01

Locations

US(1)