Impact Study of Community Based Treatment of Neonatal Infection by Health Extension Workers on Neonatal Mortality

Study Overview
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Brief Summary
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The purpose of the study is to determine whether community based management of infections with antibiotics administered by health extension workers reduce all cause mortality in neonates after the first day of life compared to current MOH IMNCI model of referral to hospital

Detailed Description
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Although 44% of neonatal deaths in Ethiopia are due to infection, access to treatment for neonatal infections is very low for most families. Even though the newly adapted Integrated Management of Newborn and Childhood Illness (IMNCI) package includes assessment of newborns, if a baby has any danger signs that may be suggestive of infection and is taken to health posts, the baby is to be referred to hospital for treatment. Given that only about 5% of neonatal deaths occur in hospitals and the distance to hospital is often far and the costs prohibitive, very few babies are likely to receive essential lifesaving antibiotics. Evidence from India, Bangladesh, and Nepal demonstrates that community health workers can effectively manage neonatal infections at home. However it is not known whether and community-based management of neonatal infections is effective, feasible and acceptable in the Ethiopian context. Local evidence regarding lives saved and cost is required in order to inform health policy and programming regarding community-based treatment of neonatal infections.

Official Title
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Impact of Strengthened Health Extension Program and Community Based Treatment of Neonatal Infections on Neonatal Mortality in Oromia and South Nation and Nationalities & People Region(SNNPR), Ethiopia

Conditions
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Neonatal Infections

Intervention / Treatment
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* Other: Community Based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who give consent to be treated at Health Post by Health extension worker Exclusion Criteria: If Newborn is Critically sick

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 4 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Arm1<br>Make a diagnosis of Neonatal infections and refer patients according to IMNCI guideline | |
| Active Comparator: 2<br>Health extension Workers will Make a diagnosis of Neonatal infections and treat with antibiotics when referal is not possible | Other: Community Based<br>* In Arm 2 health extension workers will make a diagnosis of Neonatal infection and treat with antibiotics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause Neonatal Mortality |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional cost for community based neonatal infection management |  | 2 years | 
| Adding identification and treatment of newborns and children to the package of services provided by HEWs/CHPs will not adversely affect the coverage of other services currently provided. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ethiopia, Community, Community based, Health extension Worker, Health Extension Program