Improving Newborn Survival In Southern Tanzania (INSIST)

London School of Hygiene and Tropical Medicine

Status: Completed

Conditions: Newborn Health

Treatments: Behavioral: Home-based counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT01022788

5316

Details and patient eligibility

About

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.

Enrollment: 47,688 patients

Sex: All

Ages: Under 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women living in the study area

Exclusion criteria

• Unwilling to participate

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47,688 participants in 2 patient groups

Home-based counselling visits by volunteers

Experimental group

Description:

Home-based counselling in pregnancy and the first few days of life to encourage women and families to adopt key newborn care behaviours

Treatment:

Behavioral: Home-based counselling

Standard care through existing health system

No Intervention group