Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care

November 21, 2017 updated by: Penn State University
In the United States (U.S.) there currently is no standard method of umbilical cord care, resulting in varying practices within and across institutions. These differences may result in an increase in morbidities for newborns such as the formation of umbilical granulomas and increases in acute care utilization. This study will determine which of two common methods of caring for newborn umbilical cords is superior - triple dye, followed by the application of rubbing alcohol, or triple dye alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infection of the umbilical cord of the newborn is a serious condition that can even lead to infant death. It has been well documented that the sources of infection among infants in hospitals is cross-contamination from other infants; S aureus is carried from infant to infant by nursery caregivers. Current and accepted cord care practices include aseptic techniques in cutting the umbilical cord, applying antimicrobial agents, hand washing, dry cord care and rolling the diaper below the cord to enhance drying (Evens, et. al, 2004).

Many studies have been performed to identify the best cord care practice. Zupan, et. al (2004) performed a meta-analysis of 21 studies that investigated cord care. Between all 21 studies many antimicrobial agents were used, including alcohol, triple dye, silver sulfadiazine, zinc powder, chlorhexidine, and salicylic sugar powder, along with dry cord care. It was identified that limited research has not shown a significant difference in outcomes between antimicrobial agent use and simply keeping the cord clean and dry. In high-income countries where mortality is low, important outcomes must include infections in the first month of life, maternal satisfaction, and time to cord separation. At the current time, there is no research that identifies the usefulness of applying colostrum, which has bacteriostatic properties, to the umbilical cord.

A prospective controlled trial was conducted by Golombek, S., et. al (2002) to compare only cord separation times between infants treated with triple dye as compared to alcohol. Of the 634 patients enrolled, one infant in the triple dye group was diagnosed with omphalitis; and one infant in the alcohol group was diagnosed with an ear infection. There was a statistically significant difference in cord separation time, with the alcohol group having a shorter separation time by 3 days (alcohol group 10 days, versus triple dye group 13 days) (p<0.0001). Nursing staff reported more satisfaction with alcohol alone. Parents universally expressed relief with cord separation in both groups.

Janssen, P., et al (2003) compared cord bacterial colonization and morbidity among newborns whose cords were treated with triple dye and alcohol versus dry cord care. Seven hundred sixty six infants were enrolled and randomized to a triple dye and alcohol group or a dry cord care group. Study groups were similar in all respects. Significantly more mothers in the dry care group stated that their infant's physician had mentioned concerns about infection to them compared with none in the triple dye group. There were no differences in reported rates of mothers contacting physicians in regard to concerns about infection. The most significant difference of observations of community health nurses between the two groups was periumbilical area exudates (p< 0.001) and foul odor (p<0.04) was more noticed in the dry cord care group. Though only one infant in the entire study developed omphalitis, which was in the dry cord care group, infants in the dry care group were significantly more likely to be colonized by E. coli, coag-neg staph, S. aures, and group B strep. Topical antimicrobial cord care may reduce bacterial colonization of the cord; there is no firm relationship between colonization and infection. Parents have expressed apprehension about cleaning the cord because of it's black appearance and brittle, rigid texture suggest that it will break off or hurt the infant if touched. Though not reported in scientific literature, increasing rates of breastfeeding may offer some protection to the newborn from infection. The study suggests that omphalitis remains a clinical entity and that there is potential risk in discontinuing bacteriocidal treatment of the umbilical cord stump. Cessation of bactericidal care of the umbilical stump must be accompanied by vigilant attention and education of parents to the signs and symptoms of omphalitis.

Study Type

Interventional

Enrollment

400

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newborn admitted to the well-baby nursery
  • >= 37 weeks gestation
  • Born at Hershey Medical Center
  • University Pediatric Associates patient

Exclusion Criteria:

  • Baby with sepsis or admitted to the Neonatal Intensive Care Unit (NICU)
  • <37 weeks gestation
  • Not being followed by University Pediatric Associates

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine which of two common methods of caring for newborn umbilical cords is superior, triple dye followed by application of rubbing alcohol or triple dye alone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penn State University

Collaborators

Children's Miracle Network

Investigators

  • Principal Investigator: Alawia Suliman, MD, Penn State College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

August 5, 2005

First Submitted That Met QC Criteria

August 5, 2005

First Posted (Estimate)

August 8, 2005

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21353EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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