Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127699
Status:
COMPLETED
Last Update Posted:
2017-11-24
First Post:
2005-08-05
Brief Title:
Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care
Sponsor:
Penn State University
Organization:
Penn State University
Study Overview
Official Title:
Triple Dye Plus Alcohol Versus Triple Dye Alone for Newborn Umbilical Cord Care
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the United States US 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
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 p00001 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 infants 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 0001 and foul odor p004 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 its 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
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 p00001 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 infants 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 0001 and foul odor p004 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 its 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None