Umbilical Cord Care for the Prevention of Colonization

NCT01893060 | Unknown

• 1 other identifier: 16859
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 University of Virginia (UVA) NICU. The study hypothesizes that twice 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.

Conditions

Line Insertion Site; Central Line-associated Bloodstream Infection (CLABSI)

Keywords

Prematurity; Central line care; Umbilical line colonization; Colonization; Newborn Intensive Care Unit; Neonatal Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Colonization of umbilical stump

  While umbilical lines are in place, average of 7 days

Secondary Outcomes (2)

• Late-onset infection

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

• Contact dermatitis of cord or skin base

  while lines are in place, average of 7 days

Study Arms (4)

Povidone-Iodine

EXPERIMENTAL

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

Drug: Chlorhexidine gluconate

Pluronic Cream

EXPERIMENTAL

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

Drug: Pluronic Cream

Control

SHAM COMPARATOR

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

Other: control

Interventions

Povidone-Iodine DRUG

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

Also known as: Betadine

Povidone-Iodine

Chlorhexidine gluconate DRUG

Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place

Also known as: ChloraPrep®

Chlorhexidine

Pluronic Cream DRUG

Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place

Also known as: Pluronic Gel, Pluronic

Pluronic Cream

control OTHER

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

Also known as: Sham control

Control

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia HealthSystem

Charlottesville, Virginia, 22932, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Povidone-Iodine; chlorhexidine gluconate; Poloxamer

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Polyethylene Glycols; Ethylene Glycols; Glycols; Alcohols

Study Officials

• David A Kaufman, MD

  UVA School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Kaufman, MD

CONTACT

434-924-9114; dak4r@virginia.edu

Amy E Blackman, BSN

CONTACT

434-982-0263; as5v@virginia.edu

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 20, 2013
• First Posted: July 8, 2013
• Study Start: July 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

US (1)