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

Primary Purpose

Neonatal Infections

Status
Completed
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Community Based
Sponsored by
Save the Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neonatal Infections focused on measuring Ethiopia, Community, Community based, Health extension Worker, Health Extension Program

Eligibility Criteria

1 Minute - 4 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • Sidama, East shoa and West arsi Zones

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Arm1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

All cause Neonatal Mortality

Secondary Outcome Measures

Additional cost for community based neonatal infection management
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.

Full Information

First Posted
August 28, 2008
Last Updated
September 18, 2019
Sponsor
Save the Children
Collaborators
John Snow, Inc., University of London, UNICEF
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1. Study Identification

Unique Protocol Identification Number
NCT00743691
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Save the Children
Collaborators
John Snow, Inc., University of London, UNICEF

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Infections
Keywords
Ethiopia, Community, Community based, Health extension Worker, Health Extension Program

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19476 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm1
Arm Type
No Intervention
Arm Description
Make a diagnosis of Neonatal infections and refer patients according to IMNCI guideline
Arm Title
2
Arm Type
Active Comparator
Arm Description
Health extension Workers will Make a diagnosis of Neonatal infections and treat with antibiotics when referal is not possible
Intervention Type
Other
Intervention Name(s)
Community Based
Intervention Description
In Arm 2 health extension workers will make a diagnosis of Neonatal infection and treat with antibiotics
Primary Outcome Measure Information:
Title
All cause Neonatal Mortality
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Additional cost for community based neonatal infection management
Time Frame
2 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
4 Weeks
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel T. Tesema, MD,Ped
Organizational Affiliation
Save the Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brian E. Mulligan, BSc, MPH
Organizational Affiliation
John Snow, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tedbab D. HaileGebreil, MD, Ped
Organizational Affiliation
Save the Children/USA Ethiopia country office
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon Ni Cousens, professor
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidama, East shoa and West arsi Zones
City
Ādama
State/Province
Sidama
Country
Ethiopia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11336143
Citation
Ahmed S, Sobhan F, Islam A, Barkat-e-Khuda. Neonatal morbidity and care-seeking behaviour in rural Bangladesh. J Trop Pediatr. 2001 Apr;47(2):98-105. doi: 10.1093/tropej/47.2.98.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
10622298
Citation
Bang AT, Bang RA, Baitule SB, Reddy MH, Deshmukh MD. Effect of home-based neonatal care and management of sepsis on neonatal mortality: field trial in rural India. Lancet. 1999 Dec 4;354(9194):1955-61. doi: 10.1016/S0140-6736(99)03046-9.
Results Reference
background
PubMed Identifier
15866863
Citation
Bhutta ZA, Darmstadt GL, Hasan BS, Haws RA. Community-based interventions for improving perinatal and neonatal health outcomes in developing countries: a review of the evidence. Pediatrics. 2005 Feb;115(2 Suppl):519-617. doi: 10.1542/peds.2004-1441.
Results Reference
background
Citation
Lawn JE, Cousens S, Zupan J for the Lancet Neonatal Survival Steering Team. 4 million deaths: When? Where? Why? Published online March 3 2005. http://image.thelancet.com/extras/05art1073web.pdf.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
16556647
Citation
Lawn JE, Wilczynska-Ketende K, Cousens SN. Estimating the causes of 4 million neonatal deaths in the year 2000. Int J Epidemiol. 2006 Jun;35(3):706-18. doi: 10.1093/ije/dyl043. Epub 2006 Mar 23.
Results Reference
background
Citation
FMOHa. Health Sector Development Programme -III Document. Federal Ministry of Health, Addis Ababa, Ethiopia, November 2005.
Results Reference
background
PubMed Identifier
10342698
Citation
Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.
Results Reference
background
PubMed Identifier
28611102
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.
Results Reference
derived
Links:
URL
http://www.savethechildren.org
Description
Official website for Save the Children

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

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