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Improving Newborn Survival In Southern Tanzania (INSIST)

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ClinicalTrials.gov Identifier: NCT01022788
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : April 28, 2015
Sponsor:
Collaborators:
Save the Children
UNICEF
Information provided by (Responsible Party):
Joanna Schellenberg, 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.


Condition or disease Intervention/treatment Phase
Newborn Health Behavioral: Home-based counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47688 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official 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
Study Start Date : January 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : March 2014

Arm Intervention/treatment
Experimental: Home-based counselling visits by volunteers
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
Other Name: Mtunze Mtoto Mchanga

No Intervention: Standard care through existing health system



Primary Outcome Measures :
  1. Newborn survival (to 28 days) [ Time Frame: July 2010 to June 2013 ]

Secondary Outcome Measures :
  1. Household behaviours for essential newborn care [ Time Frame: July 2010 to June 2013 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women living in the study area

Exclusion Criteria:

  • Unwilling to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022788


Locations
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Tanzania
Mtwara R, Tandahimba, Newala, Nachingwea, Lindi R, Ruangwa, Mtwara and Lindi Regions, Tanzania
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Save the Children
UNICEF
Investigators
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Principal Investigator: David Schellenberg LSHTM
Principal Investigator: Hassan Mshinda Ifakara Health Institute and COSTECH
Principal Investigator: Marcel Tanner Swiss Tropical & Public Health Institute
Principal Investigator: Fatuma Manzi, PhD Ifakara Health Institute, Tanzania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joanna Schellenberg, Professor of Epidemiology and International Health, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01022788     History of Changes
Other Study ID Numbers: 5316
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015