- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00743691
Impact Study of Community Based Treatment of Neonatal Infection by Health Extension Workers on Neonatal Mortality
September 18, 2019 updated by: Save the Children
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
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
19476
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sidama
-
Ādama, Sidama, Ethiopia
- Sidama, East shoa and West arsi Zones
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 4 weeks (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants who give consent to be treated at Health Post by Health extension worker
Exclusion Criteria:
- If Newborn is Critically sick
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Arm1
Make a diagnosis of Neonatal infections and refer patients according to IMNCI guideline
|
|
Active Comparator: 2
Health extension Workers will Make a diagnosis of Neonatal infections and treat with antibiotics when referal is not possible
|
In Arm 2 health extension workers will make a diagnosis of Neonatal infection and treat with antibiotics
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All cause Neonatal Mortality
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Additional cost for community based neonatal infection management
Time Frame: 2 years
|
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.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 and Tropical Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1093/tropej/47.2.98.
- 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
- 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.
- 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.
- 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.
- 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, 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.
- 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. doi: 10.1093/ije/28.2.319.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
August 28, 2008
First Submitted That Met QC Criteria
August 28, 2008
First Posted (Estimate)
August 29, 2008
Study Record Updates
Last Update Posted (Actual)
September 20, 2019
Last Update Submitted That Met QC Criteria
September 18, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SNL 50124
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Infections
-
Aga Khan UniversityUniversity of Sydney; The International Federation of Red Cross and Red Crescent...Completed
-
Centre Hospitalier Universitaire de Saint EtienneCompletedStreptococcus Agalactiae | Neonatal InfectionsFrance
-
Jip GroenInBiomeRecruitingMicrobial Colonization | Neonatal Infection | Neonatal Sepsis, Early-Onset | Microbial Disease | Clinical Sepsis | Culture Negative Neonatal Sepsis | Neonatal Sepsis, Late-Onset | Culture Positive Neonatal SepsisNetherlands
-
University of Colorado, DenverEnrolling by invitation
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
Johns Hopkins Bloomberg School of Public HealthMRC/UVRI and LSHTM Uganda Research Unit; Rakai Health Sciences ProgramCompletedNeonatal Male Circumcision
-
State University of New York at BuffaloUnited States Agency for International Development (USAID); Save the Children; Unilever R...Withdrawn
-
Franciscus GasthuisErasmus Medical CenterCompletedNeonatal Infection | Neonatal SEPSISNetherlands
-
Rigshospitalet, DenmarkStatens Serum InstitutCompletedNeonatal Infection | Viral Infection | Neonatal Sepsis | Neonatal Death | Herpes Simplex Virus Infection | Newborn; Infection | Neonatal Herpes Simplex Infection | Neonatal HSV InfectionDenmark
-
St George's, University of LondonAntibiotic Research UKRecruiting
Clinical Trials on Community Based
-
Chinese Academy of Medical Sciences, Fuwai HospitalRecruitingCoronary Artery DiseaseChina
-
Institut GuttmannUniversity of Vic - Central University of CataloniaRecruitingAcquired Brain Injury | Mental Health IssueSpain
-
Aga Khan UniversityYale University; Grand Challenges Canada; UNICEFUnknownChild DevelopmentPakistan
-
University of AarhusLundbeck Foundation; Sygekassernes Helsefond; Ringkjobing Amt; Ribe AmtCompletedBreastfeeding | Self-Efficacy | Practice | Maternal BehaviourDenmark
-
Sheba Medical CenterEuropean CommissionCompleted
-
University of North Carolina, Chapel HillDoris Duke Charitable FoundationCompleted
-
Eunice Kennedy Shriver National Institute of Child...CompletedTeen PregnancyUnited States
-
University of TorontoYMCACompleted
-
University of OsloLondon School of Hygiene and Tropical Medicine; University of Adelaide; University...CompletedMaternal Exposure During PregnancyMalawi
-
ANRS, Emerging Infectious DiseasesNew York University; Université Montpellier; Expertise France; Haiphong University... and other collaboratorsRecruiting