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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Newborn Antiseptic Washing and Neonatal Mortality-Nepal

Conditions
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Neonatal Mortality

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Newborn skin cleansing with 0.25% chlorhexidine solution|nan|
|Behavioral: Cleansing of umbilical cord with soap and water solution|nan|
|Behavioral: Cleansing of umbilical cord with 4% chlorhexidine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal mortality |  |  | 
| umbilical cord infection |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonatal mortality, chlorhexidine, newborn cleansing, umbilical cord care, community-based trial, prevention trial, omphalitis