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

Not Applicable

Completed

• Conditions: Neonatal Infections
• Interventions: Other: Community Based

• Registration Number: NCT00743691
• Lead Sponsor: Save the Children

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-08-28
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Start: 2009-06
• Primary Completion: 2013-06
• Study Completion: 2016-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-18
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19476

Inclusion Criteria

• Participants who give consent to be treated at Health Post by Health extension worker

Exclusion Criteria

• If Newborn is Critically sick

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
2	Community Based	Health extension Workers will Make a diagnosis of Neonatal infections and treat with antibiotics when referal is not possible

Primary Outcome Measures

Name	Time	Method
All cause Neonatal Mortality	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sidama, East shoa and West arsi Zones; 🇪🇹 Ādama, Sidama, Ethiopia