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OpenTrials
Completed

NCT Number: NCT01022788

Improving Newborn Survival In Southern Tanzania

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.

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Key information

Conditions

Age range

Up to 49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mtwara R, Tandahimba, Newala, Nachingwea, Lindi R, Ruangwa, Mtwara and Lindi Regions, Tanzania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women living in the study area

Exclusion criteria

  • Unwilling to participate

Treatment and study plan

Home-based counselling

Behavioral

Other names: Mtunze Mtoto Mchanga

Primary outcomes

  1. Newborn survival (to 28 days)

    Time frame: July 2010 to June 2013

Secondary outcomes

  1. Household behaviours for essential newborn care

    Time frame: July 2010 to June 2013

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Save the Children
  • UNICEF

Registry information

Official study title

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

Acronym: INSIST

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Dec 1, 2009
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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