Improving Newborn Survival In Southern Tanzania

Study Overview
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Brief Summary
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This study will develop, implement and evaluate the effectiveness and cost of interventions at community level (focussed on a community-based health worker) and of health system strengthening on newborn survival in rural southern Tanzania. Objectives To develop and document a community-based package for improved newborn care, focussed around interpersonal communication through home visits in pregnancy and the early neonatal period . To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level. To monitor understanding of, and attitudes related to, neonatal care and survival from both health provider and community perspectives in areas with and without the interventions. To measure incremental costs and cost savings to the health sector and society associated with the interventions, and to predict the cost of integrating the programme into routine health service provision and of scaling-up To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival. To estimate the effect of the interventions on newborn survival and household behaviours related to newborn health. Study design & methods. The interventions will be implemented in parts of Lindi and Mtwara regions. The health system quality improvement package will be implemented throughout the area and evaluated using a before-after comparison. The community intervention will be implemented initially in a randomly-chosen half of all wards (a ward is an administrative sub-area of a district). Implementation will be led by existing front-line health staff. Evaluation will include a health facility survey and a household survey to assess contacts with the agents of change, key behaviours and newborn survival in the community.

Official Title
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Improving Newborn Survival in Rural Southern Tanzania: a Study to Evaluate the Impact and Cost of a Scaleable Package of Interventions at Community Level With Health System Strengthening

Conditions
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Newborn Health

Intervention / Treatment
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* Behavioral: Home-based counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women living in the study area Exclusion Criteria: Unwilling to participate

Ages Eligible for Study
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Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based counselling visits by volunteers<br>Home-based counselling in pregnancy and the first few days of life to encourage women and families to adopt key newborn care behaviours | Behavioral: Home-based counselling<br> <br> * Other names: Mtunze Mtoto Mchanga;|
| No Intervention: Standard care through existing health system<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn survival (to 28 days) |  | July 2010 to June 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Household behaviours for essential newborn care |  | July 2010 to June 2013 |