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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00434408
Other study ID # IRB00000146
Secondary ID GHSA00030001900
Status Completed
Phase Phase 3
First received
Last updated
Start date May 2007
Est. completion date November 2010

Study information

Verified date July 2007
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% chlorhexidine cleansing solution


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 28797
Est. completion date November 2010
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender All
Age group 1 Minute to 7 Days
Eligibility Inclusion Criteria: - live-born infants delivered in one of three upazillas of Sylhet District (Zakiganj, Khanaighat, Beanibazar) - married women of reproductive age within their individual target areas listed above Exclusion Criteria: - individuals outside of the target area in Sylhet(Zakiganj, Khanaighat, Beanibazar) - infants not met at home by a project worker during the first seven days of life

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
chx once
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
CHX x 7 days
4.0% chlorhexidine cleansing of the cord during home visits by project workers for the first 7 days after birth
dry cord care
Household members are instructed to apply nothing to the newborn's umbilical cord stump.

Locations

Country Name City State
Bangladesh Rural Sylhet District Sylhet

Sponsors (5)

Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health Government of Bangladesh, International Centre for Diarrhoeal Disease Research, Bangladesh, Save the Children, Shimantik

Country where clinical trial is conducted

Bangladesh, 

References & Publications (6)

Aggett PJ, Cooper LV, Ellis SH, McAinsh J. Percutaneous absorption of chlorhexidine in neonatal cord care. Arch Dis Child. 1981 Nov;56(11):878-80. — View Citation

Baqui AH, Darmstadt GL, Williams EK, Kumar V, Kiran TU, Panwar D, Srivastava VK, Ahuja R, Black RE, Santosham M. Rates, timing and causes of neonatal deaths in rural India: implications for neonatal health programmes. Bull World Health Organ. 2006 Sep;84(9):706-13. — View Citation

Darmstadt GL, Bhutta ZA, Cousens S, Adam T, Walker N, de Bernis L; Lancet Neonatal Survival Steering Team. Evidence-based, cost-effective interventions: how many newborn babies can we save? Lancet. 2005 Mar 12-18;365(9463):977-88. — View Citation

Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. — View Citation

Mullany LC, Darmstadt GL, Khatry SK, Katz J, LeClerq SC, Shrestha S, Adhikari R, Tielsch JM. Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomised trial. Lancet. 2006 Mar 18;367(9514):910-8. — View Citation

Mullany LC, Darmstadt GL, Tielsch JM. Safety and impact of chlorhexidine antisepsis interventions for improving neonatal health in developing countries. Pediatr Infect Dis J. 2006 Aug;25(8):665-75. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary neonatal mortality 3 Month intervals
Primary omphalitis among live born infants. 3 Month intervals
Secondary newborn care practices 3 Years
Secondary care seeking behaviors 3 Years
Secondary morbidity measures, including sepsis and omphalitis 3 Years
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