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

Neonatal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743691
• Other study ID #: SNL 50124
• Status: Completed
• Phase: N/A
• Start date: June 2009
• Est. completion date: June 2016

Study information

• Verified date: September 2019
• Source: Save the Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19476
• Est. completion date: June 2016
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Weeks

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• If Newborn is Critically sick

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Neonatal Infections

Intervention

Other:
• Community Based
In Arm 2 health extension workers will make a diagnosis of Neonatal infection and treat with antibiotics

Locations

Country	Name	City	State
Ethiopia	Sidama, East shoa and West arsi Zones	Adama	Sidama

Sponsors (4)

Lead Sponsor	Collaborator
Save the Children	John Snow, Inc., UNICEF, University of London

Country where clinical trial is conducted

Ethiopia, 

References & Publications (9)

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. — View 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. — View 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

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. — View Citation

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

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

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause Neonatal Mortality		2 years
Secondary	Additional cost for community based neonatal infection management		2 years
Secondary	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.		2 years

External Links

•   Official website for Save the Children