Clinical trial NCT00434408: Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality
Official title: Impact of Umbilical Cord Cleansing With Chlorhexidine on Neonatal Mortality and Omphalitis in Rural Sylhet District of Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Omphalitis
Infection
Keywords: omphalitis
neonates
umbilical cord
infection
infant mortality
neonate morbidity
chlorhexidine
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Government of Bangladesh
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Save the Children
name: Shimantik
First posted: 2007-02-13
Enrollment: 28797
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: A community based trial that seeks to address the effect of umbilical cord cleansing using 4.0% 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: neonatal mortality
timeFrame: 3 Month intervals
measure: omphalitis among live born infants.
timeFrame: 3 Month intervals
Secondary outcomes:
measure: newborn care practices
timeFrame: 3 Years
measure: care seeking behaviors
timeFrame: 3 Years
measure: morbidity measures, including sepsis and omphalitis
timeFrame: 3 Years
Other outcomes:
Locations:
city: Sylhet
country: Bangladesh
facility: Rural Sylhet District
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Abdullah H Baqui, MBBS, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Shams El Arifeen
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1136/adc.56.11.878.
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. doi: 10.2471/blt.05.026443.
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. doi: 10.1016/S0140-6736(05)71088-6.
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. doi: 10.1016/S0140-6736(05)71048-5.
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. doi: 10.1016/S0140-6736(06)68381-5.
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. doi: 10.1097/01.inf.0000223489.02791.70.
citation: Mitra DK, Mullany LC, Harrison M, Mannan I, Shah R, Begum N, Moin MI, El Arifeen S, Baqui AH; Projahnmo Study Group in Bangladesh. Incidence and risk factors of neonatal infections in a rural Bangladeshi population: a community-based prospective study. J Health Popul Nutr. 2018 Mar 9;37(1):6. doi: 10.1186/s41043-018-0136-2.
citation: Mullany LC, Shah R, El Arifeen S, Mannan I, Winch PJ, Hill A, Darmstadt GL, Baqui AH. Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial. Pediatrics. 2013 Apr;131(4):708-15. doi: 10.1542/peds.2012-2951. Epub 2013 Mar 18.
citation: Arifeen SE, Mullany LC, Shah R, Mannan I, Rahman SM, Talukder MR, Begum N, Al-Kabir A, Darmstadt GL, Santosham M, Black RE, Baqui AH. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.
citation: Mullany LC, El Arifeen S, Winch PJ, Shah R, Mannan I, Rahman SM, Rahman MR, Darmstadt GL, Ahmed S, Santosham M, Black RE, Baqui AH. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial. BMC Pediatr. 2009 Oct 21;9:67. doi: 10.1186/1471-2431-9-67.