Improving Newborn Survival In Southern Tanzania

Not Applicable

Completed

• Conditions: Newborn Health
• Interventions: Behavioral: Home-based counselling

• Registration Number: NCT01022788
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

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

1. 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 .

2. To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.

3. To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.

4. 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.

5. 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

6. To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.

7. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-12-01
• Study Start: 2010-01
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47688

Inclusion Criteria

• Pregnant women living in the study area

Exclusion Criteria

• Unwilling to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based counselling visits by volunteers	Home-based counselling	Home-based counselling in pregnancy and the first few days of life to encourage women and families to adopt key newborn care behaviours

Primary Outcome Measures

Name	Time	Method
Newborn survival (to 28 days)	July 2010 to June 2013

Secondary Outcome Measures

Name	Time	Method
Household behaviours for essential newborn care	July 2010 to June 2013