NCT01886001

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

June 17, 2013

Last Update Submit

April 30, 2018

Conditions

Colonization

Keywords

Newborn Intensive Care UnitNeonatal Intensive Care UnitColonizationLine ColonizationUmbilical lineUmbilical Cord Care

Outcome Measures

Primary Outcomes (1)

  • Colonization of umbilical stump

    while umbilical lines are in place which is an average of 7 days

Secondary Outcomes (2)

  • Late-onset infection

    up to 120 days of life, transfer, death or discharge from NICU

  • contact dermatitis

    during intervention which is an average of 7 days

Study Arms (4)

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

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

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

Drug: Pluronic

Control (no application)

SHAM COMPARATOR

Control arm, no product is applied, which is standard of care.

Other: Control

Interventions

Povidone-IodineDRUG

Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place

Also known as: Betadine
Povidone-Iodine (Betadine)
ChlorhexidineDRUG

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

Also known as: ChloraPrep®, Chlorhexidine Gluconate 2% w/v;70% Isopropyl Alcohol
Chlorhexidine
PluronicDRUG

Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin)applied once a day to cord stump while umbilical line(s) are in place

Also known as: Pluronic Gel
Pluronic
ControlOTHER

No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.

Control (no application)

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \*≤7 days of life
  • \*Umbilical line(s) in place (UAC and/or UVC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Interventions

Povidone-IodineChlorhexidinechlorhexidine gluconateEthanolPoloxamer

Intervention Hierarchy (Ancestors)

IodophorsIodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureBiguanidesGuanidinesAmidinesAlcoholsPolyethylene GlycolsEthylene GlycolsGlycols

Study Officials

  • David A Kaufman, MD

    UVA School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 17, 2013

First Posted

June 25, 2013

Study Start

November 1, 2012

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

May 3, 2018

Record last verified: 2018-04

Locations

US(1)