CatheterizationPhase 4NCT00516360
Study of Chlorhexidine as the Hub Antiseptic to Prevent Catheter Related Infections in Newborn Infants
A Phase 4 study testing 3.15% chlorhexidine as daily antiseptic on needleless access port in people with Catheterization, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to prevent catheter-related infections in newborn infants admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of microbes in catheters. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Catheterization
- What is being tested?
- 3.15% chlorhexidine as daily antiseptic on needleless access port
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to the NICU
- Umbilical vein catheter or peripherally inserted central venous catheter (PICC) anticipated to be in place for more than 48 hours
- Parent or guardian able to give informed consent prior to first hyperalimentation and total parenteral nutrition tubing change
Who cannot join
- Known CRBSI-positive blood culture at the time of catheter line placement.
- Not expected to survive for more than 48 hours
- Broviac or any other surgically-placed central catheters
- Any condition that, as determined by the investigator, would interfere with evaluation of the line or be a potential health risk to the participant
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Erik S. Thingvoll, MD, 585-275-1847, erik_thingvoll@urmc.rochester.edu
Carl D'Angio, MD, 585-275-5884, carl_dangio@urmc.rochester.edu
About this study
Official title: Chlorhexidine and the Prevention of Central Catheter Related Infections in Neonates
The purpose of this study is to prevent catheter-related infections in newborn infants admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of microbes in catheters.
Read the detailed description
Catheter-related bloodstream infections (CRBSIs) are a major cause of morbidity and mortality in infants admitted to the NICU. In adults, chlorhexidine used as a skin antiseptic has been shown to reduce the incidence of CRBSIs, and recent evidence indicates the inner surface of long-term central catheters as the likely route of infection. This study will evaluate 3.15% chlorhexidine as the daily catheter hub antiseptic to reduce catheter tip microbial colonization, an indication of high risk for acquiring CRBSI. The purpose of this study is to compare the antiseptic capability of 3.15% chlorhexidine versus isopropyl alcohol in reducing central catheter-related infections in neonates. This study also aims to compare the time to catheter hub microbial colonization in the two groups and to determine the route of catheter tip colonization by comparing cultures taken from the catheter tip, hub, and skin insertion site.
This study will last 1 year. There are no study visits. The placement and removal of the catheter will be determined by the discretion of the attendant caring for the participant. Participants will be randomly assigned to one of two groups. Catheters of Group 1 participants will be treated with 3.15% chlorhexidine at the time of the daily intravenous tubing change. Catheters of Group 2 participants will be treated with isopropyl alcohol. For both groups, cultures of the inner surface of the catheter hub will be performed twice a week, and cultures of the inner surface of the catheter hub, tip, and skin insertion site will be performed upon removal of the catheter.
- Conditions
- Catheterization
- Being tested
- 3.15% chlorhexidine as daily antiseptic on needleless access port
- Keywords
- Catheter related bloodstream infections, Infant, Newborn, Intensive Care Units, Neonatal, Neonatal Central Line Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3.15% chlorhexidine as daily antiseptic on needleless access portDevice
Also called Chloraprep
3.15% chlorhexidine as daily antiseptic on needleless access port. 1 wipe used to cleanse port each time the port is accessed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chlorhexidien as the antibacterial agent used to cleanse the hub of neonatal central lines Receives: Device: 3.15% chlorhexidine as daily antiseptic on needleless access port |
| 2 | Active comparator | Isopropyl alcohol as the antibacterial agent used to cleanse the hub of neonatal central lines Receives: Device: 3.15% chlorhexidine as daily antiseptic on needleless access port |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter tip microbial colonization
Measured: at the time of catheter removal
Secondary outcomes (2)
Time to hub microbial colonization
Measured: at the time of catheter removal
Route of catheter tip microbial colonization determined by cultures taken at the catheter hub versus skin
Measured: at the time of catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CatheterizationStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Rochester
- Investigators
- Erik S. Thingvoll, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516360
- Sponsor's protocol ID
- T32AI007464
- Other IDs
- 00016854
- Status last verified
- Aug 2007
- First submitted
- 13 Aug 2007
- Last updated
- 30 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garland JS, Alex CP, Mueller CD, Otten D, Shivpuri C, Harris MC, Naples M, Pellegrini J, Buck RK, McAuliffe TL, Goldmann DA, Maki DG. A randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates. Pediatrics. 2001 Jun;107(6):1431-6. doi: 10.1542/peds.107.6.1431.
PubMed 11389271Garland JS, Henrickson K, Maki DG; 2002 Hospital Infection Control Practices Advisory Committee Centers for Disease Control and Prevention. The 2002 Hospital Infection Control Practices Advisory Committee Centers for Disease Control and Prevention guideline for prevention of intravascular device-related infection. Pediatrics. 2002 Nov;110(5):1009-13. doi: 10.1542/peds.110.5.1009. No abstract available.
PubMed 12415044
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorhexidine and the Prevention of Central Catheter Related Infections in Neonates
- ClinicalTrials.gov ID
- NCT00516360
- Acronym / sponsor ID
- T32AI007464
- Conditions
- Catheterization
- Keywords
- Catheter related bloodstream infections, Infant, Newborn, Intensive Care Units, Neonatal, Neonatal Central Line Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- University of Rochester
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 15 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prevent catheter-related infections in newborn infants admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of microbes in catheters.
Detailed description
Catheter-related bloodstream infections (CRBSIs) are a major cause of morbidity and mortality in infants admitted to the NICU. In adults, chlorhexidine used as a skin antiseptic has been shown to reduce the incidence of CRBSIs, and recent evidence indicates the inner surface of long-term central catheters as the likely route of infection. This study will evaluate 3.15% chlorhexidine as the daily catheter hub antiseptic to reduce catheter tip microbial colonization, an indication of high risk for acquiring CRBSI. The purpose of this study is to compare the antiseptic capability of 3.15% chlorhexidine versus isopropyl alcohol in reducing central catheter-related infections in neonates. This study also aims to compare the time to catheter hub microbial colonization in the two groups and to determine the route of catheter tip colonization by comparing cultures taken from the catheter tip, hub, and skin insertion site.
This study will last 1 year. There are no study visits. The placement and removal of the catheter will be determined by the discretion of the attendant caring for the participant. Participants will be randomly assigned to one of two groups. Catheters of Group 1 participants will be treated with 3.15% chlorhexidine at the time of the daily intravenous tubing change. Catheters of Group 2 participants will be treated with isopropyl alcohol. For both groups, cultures of the inner surface of the catheter hub will be performed twice a week, and cultures of the inner surface of the catheter hub, tip, and skin insertion site will be performed upon removal of the catheter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: 3.15% chlorhexidine as daily antiseptic on needleless access portChlorhexidien as the antibacterial agent used to cleanse the hub of neonatal central lines |
| 2 | Active comparator | Device: 3.15% chlorhexidine as daily antiseptic on needleless access portIsopropyl alcohol as the antibacterial agent used to cleanse the hub of neonatal central lines |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Admitted to the NICU
- Umbilical vein catheter or peripherally inserted central venous catheter (PICC) anticipated to be in place for more than 48 hours
- Parent or guardian able to give informed consent prior to first hyperalimentation and total parenteral nutrition tubing change
Key exclusion criteria (4 listed)
- Known CRBSI-positive blood culture at the time of catheter line placement.
- Not expected to survive for more than 48 hours
- Broviac or any other surgically-placed central catheters
- Any condition that, as determined by the investigator, would interfere with evaluation of the line or be a potential health risk to the participant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3.15% chlorhexidine as daily antiseptic on needleless access portAlso: Chloraprep3.15% chlorhexidine as daily antiseptic on needleless access port. 1 wipe used to cleanse port each time the port is accessed | Device | 1, 2 |
Primary outcome
Catheter tip microbial colonization
Time frame: at the time of catheter removal
2 secondary outcomes
Time to hub microbial colonization
Time frame: at the time of catheter removal
Route of catheter tip microbial colonization determined by cultures taken at the catheter hub versus skin
Time frame: at the time of catheter removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2008.
- Background: PubMed 11389271Garland JS, Alex CP, Mueller CD, Otten D, Shivpuri C, Harris MC, Naples M, Pellegrini J, Buck RK, McAuliffe TL, Goldmann DA, Maki DG. A randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates. Pediatrics. 2001 Jun;107(6):1431-6. doi: 10.1542/peds.107.6.1431.
- Background: PubMed 12415044Garland JS, Henrickson K, Maki DG; 2002 Hospital Infection Control Practices Advisory Committee Centers for Disease Control and Prevention. The 2002 Hospital Infection Control Practices Advisory Committee Centers for Disease Control and Prevention guideline for prevention of intravascular device-related infection. Pediatrics. 2002 Nov;110(5):1009-13. doi: 10.1542/peds.110.5.1009. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik S. Thingvoll, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3.15% chlorhexidine as daily antiseptic on needleless access port in people with Catheterization, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erik S. Thingvoll, MD (585-275-1847, erik_thingvoll@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter tip microbial colonization (time frame: at the time of catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516360, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2008.