Impact Study of Community Based Treatment of Neonatal Infection by Health Extension Workers on Neonatal Mortality - Full Text View

Sponsors and Collaborators:	Save the Children John Snow, Inc. University of London UNICEF
Information provided by:	Save the Children
ClinicalTrials.gov Identifier:	NCT00743691

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

MedlinePlus related topics: Antibiotics

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Factorial Assignment, Efficacy Study
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

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:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm1: No Intervention Make a diagnosis of Neonatal infections and refer patients according to IMNCI guideline
2: Active Comparator 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 & Awassa
Sidama, East shoa and West arsi Zones
Adama & Awassa, Sidama & Awassa, Ethiopia

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 & Tropical Medicine

More Information

Official website for Save the Children This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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. Review.

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. Epub 2006 Mar 23. Review.

Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. Review.

Responsible Party:	Save the children/US, Ethiopia Country office ( Margaret M. Schuler )
Study ID Numbers:	SNL 50124
Study First Received:	August 28, 2008
Last Updated:	August 28, 2008
ClinicalTrials.gov Identifier:	NCT00743691
Health Authority:	Ethiopia: Ethiopia Science and Technology Commission

Keywords provided by Save the Children:

Ethiopia
Community
Community based
Health extension Worker
Health Extension Program

Additional relevant MeSH terms:

Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009