MedTrace Logo

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

NCT00109616 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 17000

Last updated 2013-05-01

No results posted yet for this study

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.

Conditions

  • Neonatal Mortality

Interventions

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

Sponsors & Collaborators

  • United States Agency for International Development (USAID)

    collaborator FED

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • James M Tieslch, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
10 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-10-31
Completion
2006-01-31

Countries

  • United States
  • Nepal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00109616 on ClinicalTrials.gov