Newborn HealthINSISTNCT01022788
Improving Newborn Survival In Southern Tanzania
A study testing Home-based counselling in people with Newborn Health, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Newborn Health
- What is being tested?
- Home-based counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47,688 participants
- Where
- 1 siteTanzania
- Study dates
- Jan 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women living in the study area
Who cannot join
- Unwilling to participate
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Study site
Mtwara R, Tandahimba, Newala, Nachingwea, Lindi R, Ruangwa, Mtwara and Lindi Regions
About this study
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
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
Read more
- 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 .
- To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
- To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
- 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.
- 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
- To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
- 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.
- Conditions
- Newborn Health
- Being tested
- Home-based counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based counsellingBehavioural
Also called Mtunze Mtoto Mchanga
| Study group | Role | What they receive |
|---|---|---|
| Home-based counselling visits by volunteers | Experimental | Home-based counselling in pregnancy and the first few days of life to encourage women and families to adopt key newborn care behaviours Receives: Behavioral: Home-based counselling |
| Standard care through existing health system | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn survival (to 28 days)
Measured: July 2010 to June 2013
Secondary outcomes (1)
Household behaviours for essential newborn care
Measured: July 2010 to June 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Newborn HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47,688 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children, UNICEF
- Responsible party
- Principal investigator, Joanna Schellenberg, London School of Hygiene and Tropical Medicine
- Investigators
- David Schellenberg, Principal investigator, London School of Hygiene and Tropical MedicineHassan Mshinda, Principal investigator, Ifakara Health Institute and COSTECHMarcel Tanner, Principal investigator, Swiss Tropical & Public Health InstituteFatuma Manzi, PhD, Principal investigator, Ifakara Health Institute, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022788
- Sponsor's protocol ID
- 5316
- Acronym
- INSIST
- Status last verified
- Apr 2015
- First submitted
- 27 Nov 2009
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26418813Penfold 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.
PubMed 25052850Mkumbo 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.
PubMed 24711599
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01022788
- Acronym / sponsor ID
- INSIST / 5316
- Conditions
- Newborn Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,688 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Save the Children, UNICEF
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 .
- To develop and document a quality improvement package for antenatal, intrapartum and postnatal care in health facilities.
- To implement these strategies for improved newborn survival in such a way as to be both sustainable and scaleable at national level.
- 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.
- 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
- To strengthen Tanzania's capacity to develop, implement and evaluate interventions to improve neonatal survival.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based counselling visits by volunteers | Experimental | Behavioral: Home-based counsellingHome-based counselling in pregnancy and the first few days of life to encourage women and families to adopt key newborn care behaviours |
| Standard care through existing health system | No intervention | – |
Who may qualify
- Ages
- Up to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women living in the study area
Key exclusion criteria (1 listed)
- Unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based counsellingAlso: Mtunze Mtoto Mchanga | Behavioural | Home-based counselling visits by volunteers |
Primary outcome
Newborn survival (to 28 days)
Time frame: July 2010 to June 2013
1 secondary outcome
Household behaviours for essential newborn care
Time frame: July 2010 to June 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Derived from this study: PubMed 26418813Hanson 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.
- Derived from this study: PubMed 25052850Penfold 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.
- Derived from this study: PubMed 24711599Mkumbo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Schellenberg principal investigator
London School of Hygiene and Tropical Medicine
Hassan Mshinda principal investigator
Ifakara Health Institute and COSTECH
Marcel Tanner principal investigator
Swiss Tropical & Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based counselling in people with Newborn Health, run by London School of Hygiene and Tropical Medicine at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Newborn survival (to 28 days) (time frame: July 2010 to June 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01022788, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.