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

This study has been completed.
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00127699
First received: August 5, 2005
Last updated: November 30, 2007
Last verified: November 2007
  Purpose

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.


Condition Intervention Phase
Umbilical Cord
Infection
Procedure: Alcohol swab of umbilical cord
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: August 2005
Study Completion Date: August 2007
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127699

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Children's Miracle Network
Investigators
Principal Investigator: Alawia Suliman, MD Penn State College of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Alawia Suliman, MD, Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00127699     History of Changes
Other Study ID Numbers: 21353EP
Study First Received: August 5, 2005
Last Updated: November 30, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Umbilical cord
Triple dye
Infant care

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014