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	Treatment or Intervention	Phase
Neonatal Mortality	Behavior: Newborn skin cleansing with 0.25% chlorhexidine solution  Behavior: Cleansing of umbilical cord with soap and water solution  Behavior: Cleansing of umbilical cord with 4% chlorhexidine	Phase III

Further Study Details: 

Primary Outcomes: neonatal mortality; umbilical cord infection
Expected Total Enrollment:  17000

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.

Ages Eligible for Study:  up to  10 Days,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00109616

Maryland
      Johns Hopkins Bloomberg School of Public Health, Baltimore,  Maryland,  21205-2103,  United States; Completed
Nepal
      Nepal Nutrition Intervention Project-Sarlahi, Kathmandu and Sarlahi District,  Nepal; Recruiting

Study ID Numbers:  R01 HD44004; R01 HD44004
Record last reviewed:  April 2005
Last Updated:  May 2, 2005
Record first received:  April 29, 2005
ClinicalTrials.gov Identifier:  NCT00109616
Health Authority: United States: Federal Government; Nepal: Nepal Health Research Council (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-03