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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743691
Recruitment Status : Unknown
Verified February 2009 by Save the Children.
Recruitment status was:  Not yet recruiting
First Posted : August 29, 2008
Last Update Posted : February 6, 2009
John Snow, Inc.
University of London
Information provided by:
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

Condition or disease Intervention/treatment Phase
Neonatal Infections Other: Community Based Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 660000 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 : April 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : October 2010

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

Primary Outcome Measures :
  1. All cause Neonatal Mortality [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Additional cost for community based neonatal infection management [ Time Frame: 2 years ]
  2. Community level management of pneumonia in under-five children with antibiotics by health extension workers reduces annual risk of all-cause child deaths by 20% compared to the current MOH IMNCI model of treatment only at health centers or hospitals. [ Time Frame: 2 years ]
  3. 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 ]
  4. Community-based management of neonatal infections and pneumonia in under-5s is technically feasible (i.e. correctly identified and correctly treated). [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743691

Contact: Samuel T. Tesema, MD,Ped 251 911 406525
Contact: Tedbab D. HaileGebriel, MD, Ped 251 113 720030

Sidama, East shoa and West arsi Zones Not yet recruiting
Adama & Awassa, Sidama & Awassa, Ethiopia
Contact: Samuel T. Tesema, MD, Ped    +251 113 728061 ext 291   
Contact: Tedbab D. Hailegebriel, MD, Ped    +251 113 720030   
Principal Investigator: Brian E. Mulligan, BSc, MPH         
Sponsors and Collaborators
Save the Children
John Snow, Inc.
University of London
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

Additional Information:
Baqui AH et al. Early Findings from a Cluster-randomized Community-based Newborn Health Intervention Trial in Sylhet, Bangladesh. 8th Commonwealth Congress on Diarrhoea and Malnutrition (CAPGAN), 2006
Lawn JE, Cousens S, Zupan J for the Lancet Neonatal Survival Steering Team. 4 million deaths: When? Where? Why? Published online March 3 2005.
Lawn JE and Kerber K (eds) .Opportunities for Africa's Newborns: Practical data, policy and programmatic support for newborn care in Africa. The Partnership for Maternal, Newborn & Child Health (PMNCH), Cape Town 2006. ISBN-13: 978-0-620-37695-2.
FMOHa. Health Sector Development Programme -III Document. Federal Ministry of Health, Addis Ababa, Ethiopia, November 2005.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Margaret M. Schuler, Save the children/US, Ethiopia Country office Identifier: NCT00743691     History of Changes
Other Study ID Numbers: SNL 50124
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: February 2009

Keywords provided by Save the Children:
Community based
Health extension Worker
Health Extension Program

Additional relevant MeSH terms:
Communicable Diseases