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Improving Newborn Survival In Southern Tanzania

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01022788
Acronym
INSIST
Enrollment
47688
Registered
2009-12-01
Start date
2010-01-31
Completion date
2014-03-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Health

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.

Interventions

BEHAVIORALHome-based counselling

Sponsors

Save the Children
CollaboratorOTHER
UNICEF
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 49 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women living in the study area

Exclusion criteria

* Unwilling to participate

Design outcomes

Primary

MeasureTime frame
Newborn survival (to 28 days)July 2010 to June 2013

Secondary

MeasureTime frame
Household behaviours for essential newborn careJuly 2010 to June 2013

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026