Neonatal Mortality Clinical Trial
Official title:
Newborn Antiseptic Washing and Neonatal Mortality-Nepal
Neonatal mortality and morbidity is common in Nepal and the vast majority of women deliver
babies at home without a skilled birth attendant.
The purpose of this project is two-fold: 1) to evaluate whether washing a newborn child with
a dilute antiseptic solution soon after birth can reduce mortality in the first 4 weeks of
life and 2) to evaluate whether cleaning the umbilical cord and stump with either soap and
water or an antiseptic solution for the first few days of life can reduce umbilical cord
infections.
While significant progress has been made in reducing preschool child mortality in developing
countries over the past 20 years, much less progress has been made in reducing neonatal
mortality and morbidity. Neonatal mortality rates are high in Nepal; a significant
proportion of which are due to sepsis. In addition, the vast majority of women deliver
babies at home without a skilled birth attendant and early neonatal care is routinely used
in rural areas. Previous hospital-based research in Malawi suggested that newborn cleansing
with a dilute chlorhexidine solution could reduce early infant mortality. This project
evaluates the use of a simple intervention at the community level and the impact on neonatal
mortality.
Comparisons: Two nested community-based randomized trials are being conducted. The first
compares the neonatal mortality rates between newborn infants randomized to receive a whole
body skin cleansing soon after birth with baby wipes impregnated with 0.25% chlorhexidine
compared with newborns cleaned with baby wipes with a placebo solution. The second trial
compares the rates of umbilical cord infections among children assigned to three groups:
- education of the mother on clean cord care alone;
- education of the mother plus routine washing of the cord and stump with soap and water
solution for the first 10 days of life; -OR-
- education of the mother plus routine washing of the cord and stump with a 4%
chlorhexidine solution.
Enrolled infants are visited on a regular basis during the first month of life to record
vital status and grade the cord for signs of infection.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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