Clinical trial NCT01022788: Improving Newborn Survival In Southern Tanzania
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Health
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Save the Children
name: UNICEF
First posted: 2009-12-01
Enrollment: 47688
Sex: ALL
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* Pregnant women living in the study area

Exclusion Criteria:

* Unwilling to participate

Primary outcomes:
measure: Newborn survival (to 28 days)
timeFrame: July 2010 to June 2013
Secondary outcomes:
measure: Household behaviours for essential newborn care
timeFrame: July 2010 to June 2013
Other outcomes:
Locations:
city: Mtwara R, Tandahimba, Newala, Nachingwea, Lindi R, Ruangwa
country: Tanzania
state: Mtwara and Lindi Regions
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: David Schellenberg
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute and COSTECH
name: Hassan Mshinda
role: PRINCIPAL_INVESTIGATOR
affiliation: Swiss Tropical & Public Health Institute
name: Marcel Tanner
role: PRINCIPAL_INVESTIGATOR
affiliation: Ifakara Health Institute, Tanzania
name: Fatuma Manzi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanson C, Manzi F, Mkumbo E, Shirima K, Penfold S, Hill Z, Shamba D, Jaribu J, Hamisi Y, Soremekun S, Cousens S, Marchant T, Mshinda H, Schellenberg D, Tanner M, Schellenberg J. Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania. PLoS Med. 2015 Sep 29;12(9):e1001881. doi: 10.1371/journal.pmed.1001881. eCollection 2015 Sep.
citation: Penfold S, Manzi F, Mkumbo E, Temu S, Jaribu J, Shamba DD, Mshinda H, Cousens S, Marchant T, Tanner M, Schellenberg D, Schellenberg JA. Effect of home-based counselling on newborn care practices in southern Tanzania one year after implementation: a cluster-randomised controlled trial. BMC Pediatr. 2014 Jul 22;14:187. doi: 10.1186/1471-2431-14-187.
citation: Mkumbo E, Hanson C, Penfold S, Manzi F, Schellenberg J. Innovation in supervision and support of community health workers for better newborn survival in southern Tanzania. Int Health. 2014 Dec;6(4):339-41. doi: 10.1093/inthealth/ihu016. Epub 2014 Apr 7.