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

NCT00743691 | Completed DMC

• 1 other identifier: SNL 50124
• Study Type: interventional
• Target: 19,476
• Locations: 1 country
• Sites: 1

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

Conditions

Neonatal Infections

Keywords

Ethiopia; Community; Community based; Health extension Worker; Health Extension Program

Outcome Measures

Primary Outcomes (1)

• All cause Neonatal Mortality

  2 years

Secondary Outcomes (2)

• Additional cost for community based neonatal infection management

  2 years

• 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

Study Arms (2)

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

Interventions

Community Based OTHER

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

2

Eligibility Criteria

• Age: 1 Minute - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• If Newborn is Critically sick

Sponsors & Collaborators

• Save the Children: lead
• John Snow, Inc.: collaborator
• University of London: collaborator
• UNICEF: collaborator

Study Sites (1)

Sidama, East shoa and West arsi Zones

Ādama, Sidama Region, Ethiopia

Location

Related Publications (10)

• 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.

  PMID: 11336143 BACKGROUND

• 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

  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.

  PMID: 10622298 BACKGROUND

• 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.

  PMID: 15866863 BACKGROUND

• 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.

  PMID: 15752534 BACKGROUND

• 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.

  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.

  PMID: 16556647 BACKGROUND

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

  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.

  PMID: 10342698 BACKGROUND

• 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.

  PMID: 28611102 DERIVED

Related Links

• Official website for Save the Children

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2008
• First Posted: August 29, 2008
• Study Start: June 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2016
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)