Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care
|First Received Date ICMJE||August 5, 2005|
|Last Updated Date||November 30, 2007|
|Start Date ICMJE||August 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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|
|Original Primary Outcome Measures ICMJE
||Determine which of two common methods of caring for newborn umbilical cords is superior, triple dye followed by application of rubbing alcohol or with triple dye alone.|
|Change History||Complete list of historical versions of study NCT00127699 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care|
|Official Title ICMJE||Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care|
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.
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 ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Intervention ICMJE||Procedure: Alcohol swab of umbilical cord|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00127699|
|Other Study ID Numbers ICMJE||21353EP|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Alawia Suliman, MD, Penn State Children's Hospital, Penn State Milton S. Hershey Medical Center|
|Study Sponsor ICMJE||Penn State University|
|Collaborators ICMJE||Children's Miracle Network|
|Information Provided By||Penn State University|
|Verification Date||November 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP