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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Save the Children.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
John Snow, Inc.
University of London
UNICEF
Information provided by:
Save the Children
ClinicalTrials.gov Identifier:
NCT00743691
First received: August 28, 2008
Last updated: February 5, 2009
Last verified: February 2009
  Purpose

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 Intervention
Neonatal Infections
Other: Community Based

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Save the Children:

Primary Outcome Measures:
  • All cause Neonatal Mortality [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional cost for community based neonatal infection management [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 660000
Study Start Date: April 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 4 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743691

Contacts
Contact: Samuel T. Tesema, MD,Ped 251 911 406525 tsamuel@savechildren.org.et
Contact: Tedbab D. HaileGebriel, MD, Ped 251 113 720030 tdegefie@savechildren.org.et

Locations
Ethiopia
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    tsamuel@savechildren.org.et   
Contact: Tedbab D. Hailegebriel, MD, Ped    +251 113 720030    tdegefie@savechildren.org.et   
Principal Investigator: Brian E. Mulligan, BSc, MPH         
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
  More Information

Additional Information:
Publications:
Responsible Party: Margaret M. Schuler, Save the children/US, Ethiopia Country office
ClinicalTrials.gov Identifier: NCT00743691     History of Changes
Other Study ID Numbers: SNL 50124
Study First Received: August 28, 2008
Last Updated: February 5, 2009
Health Authority: Ethiopia: Ethiopia Science and Technology Commission

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

ClinicalTrials.gov processed this record on April 17, 2014