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

Tracking Information

First Received Date ^ICMJE

April 29, 2005

Last Updated Date

November 2, 2006

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

neonatal mortality
umbilical cord infection

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00109616 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

17000

Completion Date

January 2006

Primary Completion Date

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

Gender

Both

Ages

up to 10 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Nepal

Administrative Information

NCT ID ^ICMJE

NCT00109616

Responsible Party

Study ID Numbers ^ICMJE

R01 HD44004, R01 HD44004

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

Information Provided By

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