Clinical trial NCT00743691: Impact Study of Community Based Treatment of Neonatal Infection by Health Extension Workers on Neonatal Mortality
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Infections
Keywords: Ethiopia
Community
Community based
Health extension Worker
Health Extension Program
Lead sponsor: Save the Children
Sponsor class: OTHER
Collaborators: name: John Snow, Inc.
name: University of London
name: UNICEF
First posted: 2008-08-29
Enrollment: 19476
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* If Newborn is Critically sick

Primary outcomes:
measure: All cause Neonatal Mortality
timeFrame: 2 years
Secondary outcomes:
measure: Additional cost for community based neonatal infection management
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: Ādama
country: Ethiopia
facility: Sidama, East shoa and West arsi Zones
state: Sidama
Study officials:
affiliation: Save the Children
name: Samuel T. Tesema, MD,Ped
role: PRINCIPAL_INVESTIGATOR
affiliation: John Snow, Inc.
name: Brian E. Mulligan, BSc, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Save the Children/USA Ethiopia country office
name: Tedbab D. HaileGebreil, MD, Ped
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Simon Ni Cousens, professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.
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citation: Degefie Hailegebriel T, Mulligan B, Cousens S, Mathewos B, Wall S, Bekele A, Russell J, Sitrin D, Tensou B, Lawn J, de Graft Johnson J, Legesse H, Hailu S, Nigussie A, Worku B, Baqui A. Effect on Neonatal Mortality of Newborn Infection Management at Health Posts When Referral Is Not Possible: A Cluster-Randomized Trial in Rural Ethiopia. Glob Health Sci Pract. 2017 Jun 27;5(2):202-216. doi: 10.9745/GHSP-D-16-00312. Print 2017 Jun 27.