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

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ClinicalTrials.gov Identifier: NCT00109616
Recruitment Status : Completed
First Posted : May 2, 2005
Last Update Posted : May 1, 2013
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)

Tracking Information
First Submitted Date  ICMJE April 29, 2005
First Posted Date  ICMJE May 2, 2005
Last Update Posted Date May 1, 2013
Study Start Date  ICMJE October 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • neonatal mortality
  • umbilical cord infection
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Community Trial of Newborn Skin and Umbilical Cord Cleansing on Neonatal Mortality in Nepal
Official Title  ICMJE Newborn Antiseptic Washing and Neonatal Mortality-Nepal
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Neonatal Mortality
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
17000
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 10 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nepal,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00109616
Other Study ID Numbers  ICMJE R01HD044004( U.S. NIH Grant/Contract )
R01HD044004 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators  ICMJE
  • United States Agency for International Development (USAID)
  • Bill and Melinda Gates Foundation
Investigators  ICMJE
Principal Investigator: James M Tieslch, PhD Johns Hopkins Bloomberg School of Public Health
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date January 2006

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