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

Sponsor

Save the Children (Other)

Overall Status

Completed

CT.gov ID

NCT00743691

Collaborator

John Snow, Inc. (Industry), University of London (Other), UNICEF (Other)

19,476

Enrollment

Location

Arms

Duration (Months)

231.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Neonatal Infections	Other: Community Based	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

19476 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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 Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Arm1

Make a diagnosis of Neonatal infections and refer patients according to IMNCI guideline

Active Comparator: 2

Health extension Workers will Make a diagnosis of Neonatal infections and treat with antibiotics when referal is not possible

Other: Community Based

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

Outcome Measures

Primary Outcome Measures

All cause Neonatal Mortality [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Minute to 4 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

If Newborn is Critically sick

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidama, East shoa and West arsi Zones	Ādama	Sidama	Ethiopia

Sponsors and Collaborators

Save the Children
John Snow, Inc.
University of London
UNICEF

Investigators

Principal Investigator: Samuel T. Tesema, MD,Ped, Save the Children
Principal Investigator: Brian E. Mulligan, BSc, MPH, John Snow, Inc.
Principal Investigator: Tedbab D. HaileGebreil, MD, Ped, Save the Children/USA Ethiopia country office
Principal Investigator: Simon Ni Cousens, professor, London School of Hygiene and Tropical Medicine