Saving Babies Lives
SBL
Design, Implementation and Assessment of a Comprehensive Community Neonatal Heath Package Utilising Medical and Social Interventions
1 other identifier
interventional
24,040
1 country
1
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. Wellcome Trust grant number 220211.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 12, 2020
CompletedFirst Posted
Study publicly available on registry
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedFebruary 19, 2026
March 1, 2024
5.2 years
November 12, 2020
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change in perinatal mortality rate as assessed using a surveillance system in Preah Vihear province
5 years
Other Outcomes (17)
Causes of death (cause-specific mortality fraction) of all stillbirths and neonates that die as assessed using a verbal autopsy tool
5 years
Change in neonatal mortality rate as assessed using a surveillance system in Preah Vihear province
5 years
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
- +14 more other outcomes
Study Arms (2)
Saving Babies Lives Programme
ACTIVE COMPARATORComprehensive neonatal healthcare package
No Saving Babies Lives Programme
PLACEBO COMPARATORControl arm
Interventions
Comprehensive neonatal healthcare package
No comprehensive neonatal healthcare package
Eligibility Criteria
You may qualify if:
- Staff members chosen by the Provincial Health Director to attend the programme
You may not qualify if:
- 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)
- 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
- Refusal to participate
- Be from a village where two members have already been chosen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Angkor Hospital for Children
Siem Reap, Cambodia
Related Publications (1)
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.
PMID: 34493225DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2020
First Posted
December 11, 2020
Study Start
January 1, 2018
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
February 19, 2026
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will share
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.