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Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal

This study has been completed.
Sponsor:
Collaborators:
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00109616
First received: April 29, 2005
Last updated: April 30, 2013
Last verified: January 2006

April 29, 2005
April 30, 2013
October 2002
Not Provided
  • neonatal mortality
  • umbilical cord infection
Same as current
Complete list of historical versions of study NCT00109616 on ClinicalTrials.gov Archive Site
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Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Neonatal Mortality
  • Behavioral: Newborn skin cleansing with 0.25% chlorhexidine solution
  • Behavioral: Cleansing of umbilical cord with soap and water solution
  • Behavioral: Cleansing of umbilical cord with 4% chlorhexidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17000
January 2006
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Inclusion Criteria:

  • All liveborn infants born in the study area

Exclusion Criteria:

  • Newborn infants who died prior to study staff arriving to conduct the interventions
Both
up to 10 Days
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Nepal
 
NCT00109616
R01 HD44004, R01 HD44004
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • United States Agency for International Development (USAID)
  • Bill and Melinda Gates Foundation
Principal Investigator: James M Tieslch, PhD Johns Hopkins Bloomberg School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP