Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434408
Status:
COMPLETED
Last Update Posted:
2022-10-05
First Post:
2007-02-09
Brief Title:
Impact of Umbilical Cord Cleansing With 40 Chlorhexidine on Neonatal Mortality
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh
Status:
COMPLETED
Status Verified Date:
2007-07
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:
CHX
Brief Summary:
A community based trial that seeks to address the effect of umbilical cord cleansing using 40 chlorhexidine cleansing solution
Detailed Description:
Of the annual four million neonatal deaths 99 occur in developing countries and more than one-third globally can be attributed to infections In areas with high-mortality rates the proportion attributable to infections is as high as 50 Many infections in infants can be prevented or treated with already existing measures yet finding the best way to provide these measures in communities that are limited in resources need to be identified Applying chlorhexidine to the umbilical cord of newborns may be a simple way to help reduce neonatal mortality and morbidity in the community at low cost
A study by our group was recently completed in Nepal It was a large community-based factorial-designed trial in southern Nepal to 1 assess the impact of newborn total body skin cleansing with 025 chlorhexidine on neonatal mortality and morbidity and 2 assess the impact of cleansing of the umbilical stump with 4 chlorhexidine on omphalitis and neonatal mortality
The results of these studies have suggested that chlorhexidine antisepsis interventions may significantly reduce neonatal mortality and omphalitis A single full body cleansing of the neonate with chlorhexidine as soon as possible after birth reduced mortality among low birth weight LBW infants by 28 Repeated cleansing of the umbilical stump with chlorhexidine reduced the rate of severe cord infection by 75 and if this treatment was begun within the first 24 hours following birth reduced neonatal mortality by 34
In rural Bangladesh over 90 of women deliver at home with only untrained local women or family members in attendance and low birth weight babies are delivered approximately 30 of the time The overall neonatal mortality rate exceeds 36 per 1000 live births and in order to reduce this burden simple cost-effective interventions that can be delivered at the community level are urgently needed Given the potential impact of repeated chlorhexidine cleansing of the cord demonstrated in the Nepal trial a replication study of this regimen and further investigations of more simple regimens are necessary The number of treatments necessary to reduce neonatal mortality has important programmatic implications for who can deliver the intervention and how it is packaged
A study by our group was recently completed in Nepal It was a large community-based factorial-designed trial in southern Nepal to 1 assess the impact of newborn total body skin cleansing with 025 chlorhexidine on neonatal mortality and morbidity and 2 assess the impact of cleansing of the umbilical stump with 4 chlorhexidine on omphalitis and neonatal mortality
The results of these studies have suggested that chlorhexidine antisepsis interventions may significantly reduce neonatal mortality and omphalitis A single full body cleansing of the neonate with chlorhexidine as soon as possible after birth reduced mortality among low birth weight LBW infants by 28 Repeated cleansing of the umbilical stump with chlorhexidine reduced the rate of severe cord infection by 75 and if this treatment was begun within the first 24 hours following birth reduced neonatal mortality by 34
In rural Bangladesh over 90 of women deliver at home with only untrained local women or family members in attendance and low birth weight babies are delivered approximately 30 of the time The overall neonatal mortality rate exceeds 36 per 1000 live births and in order to reduce this burden simple cost-effective interventions that can be delivered at the community level are urgently needed Given the potential impact of repeated chlorhexidine cleansing of the cord demonstrated in the Nepal trial a replication study of this regimen and further investigations of more simple regimens are necessary The number of treatments necessary to reduce neonatal mortality has important programmatic implications for who can deliver the intervention and how it is packaged
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GHSA00030001900 | OTHER_GRANT | Save the Children 131 | None |