A Phase 3 interventional study of chx once and CHX x 7 days in Omphalitis and Infection, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Open to participants aged 1 Minute to 7 Days. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 3, Interventional, and Prevention
A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution
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 0.25% 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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 28,797 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 364 studies on the registry; 41 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
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Exclusion Criteria:
4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
Behavioral: CHX x 7 days
4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth
Behavioral: chx once
dry cord care
Behavioral: dry cord care
4.0% chlorhexidine cleansing of the cord applied once by a project worker visiting the newborn in the home as soon as possible after birth
4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
Household members are instructed to apply nothing to the newborn's umbilical cord stump.
neonatal mortality
Time frame: 3 Month intervals
omphalitis among live born infants.
Time frame: 3 Month intervals
newborn care practices
Time frame: 3 Years
care seeking behaviors
Time frame: 3 Years
morbidity measures, including sepsis and omphalitis
Time frame: 3 Years
This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.
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Johns Hopkins Bloomberg School of Public Health