Perinatal MortalitySBLNCT04663620
Saving Babies Lives
A study testing Saving Babies Lives Programme and No Saving Babies Lives Programme in people with Perinatal Mortality, run by University of Oxford at 1 site in Cambodia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Perinatal Mortality
- What is being tested?
- Saving Babies Lives Programme and No Saving Babies Lives Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24,040 participants
- Where
- 1 siteCambodia
- Study dates
- 1 Jan 2018to 28 Feb 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Staff members chosen by the Provincial Health Director to attend the programme
- 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
Who cannot join
- 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)
- Refusal to participate
- Be from a village where two members have already been chosen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design, Implementation and Assessment of a Comprehensive Community Neonatal Heath Package Utilising Medical and Social Interventions
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.
Read the 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.
- Conditions
- Perinatal Mortality
- Being tested
- Saving Babies Lives Programme, No Saving Babies Lives Programme
- Medical subject headings
- Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saving Babies Lives ProgrammeBehavioural
Comprehensive neonatal healthcare package
No Saving Babies Lives ProgrammeBehavioural
No comprehensive neonatal healthcare package
| Study group | Role | What they receive |
|---|---|---|
| Saving Babies Lives Programme | Active comparator | Comprehensive neonatal healthcare package Receives: Behavioral: Saving Babies Lives Programme |
| No Saving Babies Lives Programme | Placebo comparator | Control arm Receives: Behavioral: No Saving Babies Lives Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (1)
Change in perinatal mortality rate as assessed using a surveillance system in Preah Vihear province
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Jan 2018
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal MortalityStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 24,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663620
- Sponsor's protocol ID
- HCR17009
- Acronym
- SBL
- Status last verified
- Mar 2024
- First submitted
- 12 Nov 2020
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 34493225
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design, Implementation and Assessment of a Comprehensive Community Neonatal Heath Package Utilising Medical and Social Interventions
- ClinicalTrials.gov ID
- NCT04663620
- Acronym / sponsor ID
- SBL / HCR17009
- Conditions
- Perinatal Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24,040 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 11 Dec 2020 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saving Babies Lives Programme | Active comparator | Behavioral: Saving Babies Lives ProgrammeComprehensive neonatal healthcare package |
| No Saving Babies Lives Programme | Placebo comparator | Behavioral: No Saving Babies Lives ProgrammeControl arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Staff members chosen by the Provincial Health Director to attend the programme
- 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
Key exclusion criteria (7 listed)
- 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)
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 |
|---|---|---|
| Saving Babies Lives ProgrammeComprehensive neonatal healthcare package | Behavioural | Saving Babies Lives Programme |
| No Saving Babies Lives ProgrammeNo comprehensive neonatal healthcare package | Behavioural | No Saving Babies Lives Programme |
Primary outcome
1. Number of new locations the Saving Babies' Lives programme is replicated in, as assessed by implementation of the programme in a new location
Time frame: 5 years
'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
1 secondary outcome
Change in perinatal mortality rate as assessed using a surveillance system in Preah Vihear province
Time frame: 5 years
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 19 Feb 2026.
- Derived from this study: PubMed 34493225Patel 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saving Babies Lives Programme and No Saving Babies Lives Programme in people with Perinatal Mortality, run by University of Oxford at 1 site in Cambodia.
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 5 inclusion and 7 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 19 Feb 2026. 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 Cambodia. 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. Some participants in this study may receive a placebo. 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?
1. Number of new locations the Saving Babies' Lives programme is replicated in, as assessed by implementation of the programme in a new location (time frame: 5 years). 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 NCT04663620, which also lists 1 linked publication.
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 19 Feb 2026.