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

NCT ID: NCT00743691

Last Updated: 2019-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Neonatal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm1

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

Group Type NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type ACTIVE_COMPARATOR

Community Based

Intervention Type OTHER

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

Interventions

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Community Based

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* If Newborn is Critically sick
Minimum Eligible Age

1 Minute

Maximum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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John Snow, Inc.

INDUSTRY

Sponsor Role collaborator

University of London

OTHER

Sponsor Role collaborator

UNICEF

OTHER

Sponsor Role collaborator

Save the Children

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel T. Tesema, MD,Ped

Role: PRINCIPAL_INVESTIGATOR

Save the Children

Brian E. Mulligan, BSc, MPH

Role: PRINCIPAL_INVESTIGATOR

John Snow, Inc.

Tedbab D. HaileGebreil, MD, Ped

Role: PRINCIPAL_INVESTIGATOR

Save the Children/USA Ethiopia country office

Simon Ni Cousens, professor

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Sidama, East shoa and West arsi Zones

Ä€dama, Sidama Region, Ethiopia

Site Status

Countries

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Ethiopia

References

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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.

Reference Type BACKGROUND
PMID: 11336143 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10622298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15866863 (View on PubMed)

Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. doi: 10.1016/S0140-6736(05)71048-5.

Reference Type BACKGROUND
PMID: 15752534 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 16556647 (View on PubMed)

FMOHa. Health Sector Development Programme -III Document. Federal Ministry of Health, Addis Ababa, Ethiopia, November 2005.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10342698 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28611102 (View on PubMed)

Related Links

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http://www.savethechildren.org

Official website for Save the Children

Other Identifiers

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SNL 50124

Identifier Type: -

Identifier Source: org_study_id

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