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

September 18, 2019 updated by: Save the Children

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sidama
      • Ādama, Sidama, Ethiopia
        • Sidama, East shoa and West arsi Zones

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • If Newborn is Critically sick

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause Neonatal Mortality
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Additional cost for community based neonatal infection management
Time Frame: 2 years
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.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 18, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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