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Saving Babies Lives (SBL)

Primary Purpose

Perinatal Mortality

Status
Recruiting
Phase
Not Applicable
Locations
Cambodia
Study Type
Interventional
Intervention
Saving Babies Lives Programme
No Saving Babies Lives Programme
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Perinatal Mortality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Angkor Hospital for ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Saving Babies Lives Programme

No Saving Babies Lives Programme

Arm Description

Comprehensive neonatal healthcare package

Control arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in perinatal mortality rate as assessed using a surveillance system in Preah Vihear province

Full Information

First Posted
November 12, 2020
Last Updated
July 15, 2022
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT04663620
Brief Title
Saving Babies Lives
Acronym
SBL
Official Title
Design, Implementation and Assessment of a Comprehensive Community Neonatal Heath Package Utilising Medical and Social Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 27, 2023 (Anticipated)
Study Completion Date
September 27, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Globally the proportion of childhood deaths that occur in the neonatal period is increasing. Since 1990 there has been a 47% reduction in deaths in children less than five years of age. However, this rate of reduction has not been seen in infants four weeks of age or younger (neonates). The reasons why the fall in neonatal mortality has not mirrored that seen in children mortality, is complex and one that is not well explored in the literature. One proposed explanation is that interventions that have been successfully employed to reduce childhood death do not reach the community and it is in the community where most neonates die. Another pervasive perceived barrier to providing neonatal care, particularly in remote and rural areas, is the misconception that neonatal care is difficult and expensive. Many health problems are rooted in powerlessness. Health education that involves community involvement: dialogue and problem solving, rather than just message giving, is more empowering. Addressing social needs and empowering communities to make decisions about health care needs allows for the design of programmes that account for local practices and beliefs. Up to two-thirds of neonatal deaths could be prevented if neonates were given proper care during and immediately after birth, because the majority of neonatal deaths occur around the time of delivery. Training primary level health care workers to deal with emergency situations that occur around the time of delivery, has been shown to decrease maternal mortality and neonatal mortality It is reported that 79% of deliveries in Cambodia occur in healthcare facilities. The majority of these will occur at primary care facilities. Babies born in primary care facilities who require further care are transferred to the referral hospital. The majority of referral hospitals in Cambodia do not have the resources or skills to effectively deal with neonatal complications for babies born either in health centres or in their on-site maternity wards. 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 the whole of Preah Vihear province in North-Eastern Cambodia, which is a rural and isolated province. A cluster is defined as a primary care administrative group, as recognised by the provincial health department, and includes all primary care facilities, primary care workers, community health workers, villagers and villages in that geographical area. The study area is divided into 21 clusters. Clusters were pre-assigned to one of two arms: intervention and control. A pilot sequence has only four clusters, to incorporate a pilot phase into study design. The intervention of this study is the Saving Babies' Lives programme which is a comprehensive, contextual and adaptive neonatal healthcare package. The Saving Babies' Lives Programme will be developed in partnership with the Kingdom of Cambodia Ministry of Health. The programme will be approved by the Ministry of Health and a memorandum of understanding signed with the provincial health director of Preah Vihear province. The control is no intervention; standard government service continues. The primary care facility intervention component of the Saving Babies' Lives programme involves course-based training combined with continuous in-situ mentoring to support doctors, nurses and midwives and other health worker cadres to improve their practical daily skills in emergency and clinical neonatal care. Essential equipment will be identified and included in the package. Meetings attended by community health workers (two from each of the villages) will be held to identify problems and concerns around neonatal health care in their own village. Monthly meetings will take place for the group to discuss problems, attempt to arrive at solutions, and share learning. These meetings will be facilitated by the study team who will use participatory action research methodology to: identify problems with provision of, and barriers to seeking, neonatal health care; develop interventions to improve care; implement these interventions; assess the group's perception of the effectiveness of interventions. A neonatal healthcare assessment tool will be developed that is quantitative and qualitative in nature. It will be based on the 'KAP' survey method of analysing Knowledge, Attitudes and Practice. In addition, two further domains will be added, equipment and staffing, leading to a 'KAPES' model of assessment. Data will be collected and used to assess the impact of the programme, its perceived facilitators and barriers and its successes and failures. This information will be used to iterate the programme content and structure in order to improve it, with the intention of creating a scalable blueprint.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Mortality

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saving Babies Lives Programme
Arm Type
Active Comparator
Arm Description
Comprehensive neonatal healthcare package
Arm Title
No Saving Babies Lives Programme
Arm Type
Placebo Comparator
Arm Description
Control arm
Intervention Type
Behavioral
Intervention Name(s)
Saving Babies Lives Programme
Intervention Description
Comprehensive neonatal healthcare package
Intervention Type
Behavioral
Intervention Name(s)
No Saving Babies Lives Programme
Intervention Description
No comprehensive neonatal healthcare package
Primary Outcome Measure Information:
Title
1. Number of new locations the Saving Babies' Lives programme is replicated in, as assessed by implementation of the programme in a new location
Description
'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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Change in perinatal mortality rate as assessed using a surveillance system in Preah Vihear province
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Causes of death (cause-specific mortality fraction) of all stillbirths and neonates that die as assessed using a verbal autopsy tool
Time Frame
5 years
Title
Change in neonatal mortality rate as assessed using a surveillance system in Preah Vihear province
Time Frame
5 years
Title
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
Time Frame
5 years
Title
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
Time Frame
5 years
Title
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
Time Frame
5 years
Title
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
Time Frame
5 years
Title
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
Time Frame
5 years
Title
Satisfaction scores of primary facility workers as assessed by a 5-point likert scale using participant feedback surveys at the end of the training
Time Frame
5 years
Title
Attendance rates of primary care workers to the training programme as assessed using attendance register records
Time Frame
5 years
Title
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
Time Frame
5 years
Title
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
Time Frame
5 years
Title
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
Time Frame
5 years
Title
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
Time Frame
5 years
Title
Attendance rates of community health workers to the monthly participatory action research meetings as assessed using attendance register records
Time Frame
5 years
Title
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
Time Frame
5 years
Title
Disability-adjusted life years averted as assessed by cost analysis of the intervention compared to normal standard of care at study end
Time Frame
5 years
Title
Quality-adjusted life years gained as assessed by cost analysis of the intervention compared to normal standard of care at study end
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Turner, MD
Phone
+85595839729
Email
claudia@tropmedres.ac
Facility Information:
Facility Name
Angkor Hospital for Children
City
Siem Reap
Country
Cambodia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Claudia Turner, MD
Phone
+85595839729
Email
claudia@tropmedres.ac

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected for this study will be under the custodianship of AHC, will be de-identified and may be shared with other groups of researchers in accordance with the current MORU Data Sharing Policy. All applications will be carefully reviewed by the MORU Data Access Committee before granting any approvals to access data. All researchers accessing the data need to adhere to a set of terms and conditions that aim to protect the interests of research participants and other relevant stakeholders.
IPD Sharing URL
https://angkorhospital.shinyapps.io/SBLP/
Citations:
PubMed Identifier
34493225
Citation
Patel K, Say S, Leng D, Prak M, Lo K, Mukaka M, Riedel A, Turner C. Saving babies' lives (SBL) - a programme to reduce neonatal mortality in rural Cambodia: study protocol for a stepped-wedge cluster-randomised trial. BMC Pediatr. 2021 Sep 7;21(1):390. doi: 10.1186/s12887-021-02833-7.
Results Reference
derived

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Saving Babies Lives

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