Impact of Umbilical Cord Cleansing With 4.0% Chlorhexidine on Neonatal Mortality
Condition: Omphalitis; Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): chx once; CHX x 7 days; dry cord care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: omphalitis; neonates; umbilical cord; infection; infant mortality; neonate morbidity; chlorhexidine