Perinatal Mortality Clinical Trial
— SBLOfficial title:
Design, Implementation and Assessment of a Comprehensive Community Neonatal Heath Package Utilising Medical and Social Interventions
Verified date | March 2024 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The central hypothesis of this study is that a neonatal healthcare programme that has a significant impact on neonatal mortality and which spans the healthcare journey from village to referral hospital can be developed and implemented in a low-resource rural setting. This study is a five-year cluster-randomised trial, covering a rural and isolated province in North-Eastern Cambodia. The intervention of this study is the Saving Babies' Lives programme, which is a comprehensive, contextual and iterative neonatal healthcare package. The Saving Babies' Lives programme comprises a training programme for primary care facilities, and participatory action research with community health workers (known in Cambodia as village health support group volunteers). The control is no intervention; standard government service continues. Qualitative and quantitative data collection supports improvements in the iterative programme, and evaluation of the study, with the intention of creating a scalable blueprint. Wellcome Trust grant number 220211.
Status | Completed |
Enrollment | 24040 |
Est. completion date | February 28, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Saving Babies Lives Training Programme Study Participants The Saving Babies Lives Programme will be aimed at government health care staff working in the community (Village Health Support Group Workers, (VHSG)), at Health Center (nurses and midwives) and at the referral hospital (doctors and nurses) Inclusion Criteria • Staff members chosen by the Provincial Health Director to attend the programme Exclusion Criteria • Not applicable Village Health Support Group Workers (VHSG) Baby Health Meetings Study Participants - Two Village Health Support Group Workers (VHSG) from villages served by each Health Center cluster - Adults (aged 18 years or older) Inclusion Criteria - Work as a government health care staff working in the community (Village Health Support Group Workers , (VHSG)) - Live in a village served by a chosen Health Center - Are able to commit to attend meetings regularly - Give consent to participate in the meetings Exclusion Criteria - Refusal to participate - Be from a village where two members have already been chosen |
Country | Name | City | State |
---|---|---|---|
Cambodia | Angkor Hospital for Children | Siem Reap |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Cambodia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Causes of death (cause-specific mortality fraction) of all stillbirths and neonates that die as assessed using a verbal autopsy tool | 5 years | ||
Other | Change in neonatal mortality rate as assessed using a surveillance system in Preah Vihear province | 5 years | ||
Other | Percentage of correct knowledge as assessed using a bespoke Knowledge, Attitudes, Practice, Equipment, Staffing annual survey for primary care facilities, change in intervention clusters compared to control clusters | 5 years | ||
Other | Percentage of positive attitudes towards neonatal care as assessed using a bespoke Knowledge, Attitudes, Practice, Equipment, Staffing survey for primary care facilities, change in intervention clusters compared to control clusters | 5 years | ||
Other | Percentage of correct practice as assessed using a bespoke Knowledge, Attitudes, Practice, Equipment, Staffing survey for primary care facilities, change in intervention clusters compared to control clusters | 5 years | ||
Other | Percentage of correct equipment available as assessed using a bespoke Knowledge, Attitudes, Practice, Equipment, Staffing survey for primary care facilities, change in intervention clusters compared to control clusters | 5 years | ||
Other | Percentage of correct staffing practice as assessed using a bespoke Knowledge, Attitudes, Practice, Equipment, Staffing survey for primary care facilities, change in intervention clusters compared to control clusters | 5 years | ||
Other | Satisfaction scores of primary facility workers as assessed by a 5-point likert scale using participant feedback surveys at the end of the training | 5 years | ||
Other | Attendance rates of primary care workers to the training programme as assessed using attendance register records | 5 years | ||
Other | Percentage of correct knowledge as assessed using a bespoke Knowledge, Attitudes, Practice annual survey for community health workers, change in intervention clusters compared to control clusters | 5 years | ||
Other | Percentage of positive attitudes towards neonatal care as assessed using a bespoke Knowledge, Attitudes, Practice survey for community health workers, change in intervention clusters compared to control clusters | 5 years | ||
Other | Percentage of correct practice as assessed using a bespoke Knowledge, Attitudes, Practice survey for community health workers, change in intervention clusters compared to control clusters | 5 years | ||
Other | Satisfaction scores of community health workers as assessed by a 5-point likert scale using participant feedback surveys at the end of the participatory action research | 5 years | ||
Other | Attendance rates of community health workers to the monthly participatory action research meetings as assessed using attendance register records | 5 years | ||
Other | Number of changes to official documentation (policy, strategy, guidelines, training materials) made by the Cambodian Ministry of Health based on the Saving Babies Lives programme as assessed by reviewing all available relevant documents at study end | 5 years | ||
Other | Disability-adjusted life years averted as assessed by cost analysis of the intervention compared to normal standard of care at study end | 5 years | ||
Other | Quality-adjusted life years gained as assessed by cost analysis of the intervention compared to normal standard of care at study end | 5 years | ||
Primary | 1. Number of new locations the Saving Babies' Lives programme is replicated in, as assessed by implementation of the programme in a new location | 'New location' is defined as consisting of at least one government-run primary care facility (and it's affiliated primary care workers and community health workers) in Cambodia that has not had the Saving Babies' Lives programme implemented before | 5 years | |
Secondary | Change in perinatal mortality rate as assessed using a surveillance system in Preah Vihear province | 5 years |
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