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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00743691
Enrollment
19476
Registered
2008-08-29
Start date
2009-06-30
Completion date
2016-06-30
Last updated
2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Infections

Keywords

Ethiopia, Community, Community based, Health extension Worker, Health Extension Program

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.

Interventions

OTHERCommunity Based

In Arm 2 health extension workers will make a diagnosis of Neonatal infection and treat with antibiotics

Sponsors

John Snow, Inc.
CollaboratorINDUSTRY
University of London
CollaboratorOTHER
UNICEF
CollaboratorOTHER
Save the Children
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 4 Weeks
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* If Newborn is Critically sick

Design outcomes

Primary

MeasureTime frame
All cause Neonatal Mortality2 years

Secondary

MeasureTime frame
Additional cost for community based neonatal infection management2 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

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026