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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| 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 |
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 III |
| 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 |
| Estimated Enrollment: | 17000 |
| Study Start Date: | October 2002 |
| Estimated Study Completion Date: | January 2006 |
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:
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and 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 | |
| Principal Investigator: | James M Tieslch, PhD | Johns Hopkins Bloomberg School of Public Health |
More Information
| ClinicalTrials.gov Identifier: | NCT00109616 History of Changes |
| Other Study ID Numbers: | R01 HD44004, R01 HD44004 |
| Study First Received: | April 29, 2005 |
| Last Updated: | February 21, 2010 |
| Health Authority: | United States: Federal Government; Nepal: Nepal Health Research Council |
|
neonatal mortality chlorhexidine newborn cleansing umbilical cord care |
community-based trial prevention trial omphalitis |
|
Chlorhexidine Chlorhexidine gluconate Anti-Infective Agents, Local Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Disinfectants Dermatologic Agents |