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
  Purpose

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.


Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Newborn Antiseptic Washing and Neonatal Mortality-Nepal

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • neonatal mortality
  • umbilical cord infection

Estimated Enrollment: 17000
Study Start Date: October 2002
Estimated Study Completion Date: January 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109616

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205-2103
Nepal
Nepal Nutrition Intervention Project-Sarlahi
Kathmandu and Sarlahi District, Nepal
Sponsors and Collaborators
United States Agency for International Development (USAID)
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: James M Tieslch, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00109616     History of Changes
Other Study ID Numbers: R01 HD44004, R01 HD44004
Study First Received: April 29, 2005
Last Updated: April 30, 2013
Health Authority: United States: Federal Government
Nepal: Nepal Health Research Council

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
neonatal mortality
chlorhexidine
newborn cleansing
umbilical cord care
community-based trial
prevention trial
omphalitis

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014