ColonizationNCT01886001
Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections
A study testing Povidone-Iodine, Chlorhexidine and Pluronic in people with Colonization, run by University of Virginia at 1 site in United States.
Trial summary
Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs). Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Colonization
- What is being tested?
- Povidone-Iodine, Chlorhexidine and Pluronic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jul 2013
- Phase
- Interventional
- 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 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤7 days of life
- Umbilical line(s) in place (UAC and/or UVC)
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Virginia Health System
Charlottesville, Virginia, 22908
About this study
Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs). This study is a prospective, randomized controlled feasibility trial to evaluate three types of hygiene products on umbilical line stumps, on the effect of line colonization and subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be randomized into one of four study groups, three products against standard of care (no product). The three products that will be evaluated are currently being used in different capacities for skin care in the UVA NICU. The study hypothesizes that daily topical application of 1 or more antiseptic to the top of the umbilical stump will decrease colonization of the umbilical stump while umbilical lines are in place.
Read the detailed description
Umbilical catheter associated infections are higher (4.4 vs. 3.4 CLABSIs per 1000 line days) than other central lines such as PICCs and surgically placed CVLin the NICU. (www.CDC.gov - NSHN 2010 Report). Routine care of the skin entry site (e.g. central line dressing care) is standard for other central lines, but there is no standard for care of the umbilical stump while umbilical lines are in place.
In a pilot study to evaluate the relationship of umbilical stump colonization with gestational age, the number of days the catheter was in place, and the type of organisms, colonization was detected in 78% of patients. There was a direct correlation with colonization and line days as well as an inverse relationship with lower gestational age.
This pilot data supported the need for the study of interventions to reduce umbilical stump colonization, which may help decrease blood stream infections (BSIs) associated with umbilical lines in the NICU. The proposed study will evaluate feasibility of once daily product application.
- Conditions
- Colonization
- Being tested
- Povidone-Iodine, Chlorhexidine, Pluronic, Control
- Keywords
- Newborn Intensive Care Unit, Neonatal Intensive Care Unit, Colonization, Line Colonization, Umbilical line, Umbilical Cord Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineDrug
Also called Betadine
Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place
ChlorhexidineDrug
Also called ChloraPrep®, Chlorhexidine Gluconate 2% w/v;70% Isopropyl Alcohol
Umbilical stump care. Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place
PluronicDrug
Also called Pluronic Gel
Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin)applied once a day to cord stump while umbilical line(s) are in place
ControlOther
No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-Iodine (Betadine) | Experimental | Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place Receives: Drug: Povidone-Iodine |
| Chlorhexidine | Experimental | Umbilical stump care. ChloraPrep® Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place Receives: Drug: Chlorhexidine |
| Pluronic | Experimental | Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied once a day to cord stump while umbilical line(s) are in place Receives: Drug: Pluronic |
| Control (no application) | Sham comparator | Control arm, no product is applied, which is standard of care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonization of umbilical stump
Measured: while umbilical lines are in place which is an average of 7 days
Secondary outcomes (2)
Late-onset infection
Late-onset infections include BSI, urinary tract infection (UTI), and meningitis. Catheter associated blood stream infections (CLABSI) for this study will be defined as growth in 1 or more blood cultures of any organism including CONS during or within 48-72 hours of having a central line in place, with signs and symptoms of sepsis, and treated for 7 days. Additionally we will compare the CDC definition of CLABSI between groups, and length of stay (LOS).
Measured: up to 120 days of life, transfer, death or discharge from NICU
contact dermatitis
Skin irritation around the umbilical stump
Measured: during intervention which is an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startNov 2012
- Primary completionMay 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonizationStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David A Kaufman, University of Virginia
- Investigators
- David A Kaufman, MD, Principal investigator, UVA School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886001
- Sponsor's protocol ID
- 16396
- Status last verified
- Apr 2018
- First submitted
- 17 Jun 2013
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: plan to analyze data and publish
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Umbilical Cord Care for the Prevention of Colonization and Invasive Infections
- ClinicalTrials.gov ID
- NCT01886001
- Acronym / sponsor ID
- 16396
- Conditions
- Colonization
- Keywords
- Newborn Intensive Care Unit, Neonatal Intensive Care Unit, Colonization, Line Colonization, Umbilical line, Umbilical Cord Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Jun 2013 (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.
Umbilical catheters are necessary for many infants admitted to the Newborn Intensive Care Unit (NICU)and utilized when indicated for up to 7 to 14 days. Bacterial colonization can occur at the umbilical stump and potentially lead to serious bloodstream infections (BSIs). This study is a prospective, randomized controlled feasibility trial to evaluate three types of hygiene products on umbilical line stumps, on the effect of line colonization and subsequent infections. Infants admitted to the NICU with an umbilical line(s) will be randomized into one of four study groups, three products against standard of care (no product). The three products that will be evaluated are currently being used in different capacities for skin care in the UVA NICU. The study hypothesizes that daily topical application of 1 or more antiseptic to the top of the umbilical stump will decrease colonization of the umbilical stump while umbilical lines are in place.
Detailed description
Umbilical catheter associated infections are higher (4.4 vs. 3.4 CLABSIs per 1000 line days) than other central lines such as PICCs and surgically placed CVLin the NICU. (www.CDC.gov - NSHN 2010 Report). Routine care of the skin entry site (e.g. central line dressing care) is standard for other central lines, but there is no standard for care of the umbilical stump while umbilical lines are in place.
In a pilot study to evaluate the relationship of umbilical stump colonization with gestational age, the number of days the catheter was in place, and the type of organisms, colonization was detected in 78% of patients. There was a direct correlation with colonization and line days as well as an inverse relationship with lower gestational age.
This pilot data supported the need for the study of interventions to reduce umbilical stump colonization, which may help decrease blood stream infections (BSIs) associated with umbilical lines in the NICU. The proposed study will evaluate feasibility of once daily product application.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine (Betadine) | Experimental | Drug: Povidone-IodineUmbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place |
| Chlorhexidine | Experimental | Drug: ChlorhexidineUmbilical stump care. ChloraPrep® Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place |
| Pluronic | Experimental | Drug: PluronicUmbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied once a day to cord stump while umbilical line(s) are in place |
| Control (no application) | Sham comparator | Other: ControlControl arm, no product is applied, which is standard of care. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- ≤7 days of life
- Umbilical line(s) in place (UAC and/or UVC)
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
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 |
|---|---|---|
| Povidone-IodineAlso: BetadineUmbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place | Drug | Povidone-Iodine (Betadine) |
| ChlorhexidineAlso: ChloraPrep®, Chlorhexidine Gluconate 2% w/v;70% Isopropyl AlcoholUmbilical stump care. Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place | Drug | Chlorhexidine |
| PluronicAlso: Pluronic GelUmbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin)applied once a day to cord stump while umbilical line(s) are in place | Drug | Pluronic |
| ControlNo product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA. | Other | Control (no application) |
Primary outcome
Colonization of umbilical stump
Time frame: while umbilical lines are in place which is an average of 7 days
2 secondary outcomes
Late-onset infection
Time frame: up to 120 days of life, transfer, death or discharge from NICU
contact dermatitis
Time frame: during intervention which is an average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Individual participant dataSharing planned: Undecided. plan to analyze data and publish
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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.
David A Kaufman, MD principal investigator
UVA School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine, Chlorhexidine and Pluronic in people with Colonization, run by University of Virginia 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 May 2018. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonization of umbilical stump (time frame: while umbilical lines are in place which is an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2018.