Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality

Infection Clinical Trial

— CHX  

Official title:

Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434408
• Other study ID #: IRB00000146
• Secondary ID: GHSA00030001900
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Infection
• Infections
• Omphalitis

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