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Trial registered on ANZCTR
Registration number
ACTRN12625000912482
Ethics application status
Approved
Date submitted
30/07/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Date data sharing statement initially provided
22/08/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Digital-based supportive supervision for newborn care providers
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Scientific title
Use of mobile phones for supportive supervision to manage quality of newborn care among healthcare providers in Lao People's Democratic Republic (PDR): A parallel cluster randomised controlled trial
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Secondary ID [1]
315031
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Newborn care
338372
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Neonatal adverse health outcomes
338373
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breast feeding
338374
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Condition category
Condition code
Public Health
334674
334674
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0
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Health service research
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Reproductive Health and Childbirth
334675
334675
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0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention will be applied at cluster (district hospital) level. The intervention includes repeated self-practice by providers augmented with mobile phone-based supportive supervision by facilitators. Self-practice will be repeated once per month for both management of breathing and non-breathing babies.
Both intervention and control arms will receive an initial refresher Early Essential Newborn Care (EENC) coaching session at each of the district hospitals. The refresher coaching session will be provided by provincial facilitators. It is a one-day session that includes inductive lectures, hands-on practice and knowledge and skill assessments on management of breathing and non-breathing babies. Standardised assessments of provider knowledge and skills will be conducted before and after the coaching sessions.
Intervention arm: The intervention group will receive:
·After the initial one-day coaching, we will conduct a one-day workshop involving providers and representatives of the Board of Directors from that district hospital. Providers will practice taking and sending videos via a new WhatsApp group using their mobile phones. A data management system that is now under development may be attached to WhatsApp to manage the data exchanged between providers and facilitators. A protocol for the data management system development is separately developed and submitted to ethics committees. We will also discuss and agree on strategies for continuing the intervention by reviewing facilitators and barriers using the pCAT (pragmatic context assessment tool) checklist. We will then assign at least one person to monitor the implementation status at each district hospital.
·Providers in the intervention arm will conduct bi-weekly simulation-based self-practising on essential newborn care (once in a month each for management of breathing and non-breathing baby) alongside their clinical duties. They will also be encouraged to send videos of their performance during practice sessions to provincial facilitators bi-weekly, using the Social Network Service (SNS).
·We expect at least two videos per provider per month period will be sent to provincial facilitators.
·Provincial facilitators will review the videos and send feedback on how to handle newborns based on the EENC guidelines via the group SNS.
·As central facilitators are also members of this group, they can also provide individual feedback to the provincial facilitators regarding the comments they provided to district staff. We anticipate this will help provincial facilitators to improve their supervisory and feedback skills.
·The self-practise supported by the mobile phone-based supervision will continue for 12 months.
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Intervention code [1]
331629
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Behaviour
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Comparator / control treatment
Control arm: Hospitals in the control arm will follow current standard practice (no follow-up educational interventions for providers). During the initial coaching, healthcare providers will be encouraged to continue their own daily practice, but there is no additional support after the initial coaching visit.
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Control group
Active
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Outcomes
Primary outcome [1]
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EENC skills among district healthcare providers at 12 months post coaching (Skill score)
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Assessment method [1]
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We will use a standardised simulation test, developed by WHO regional office for the Western Pacific, to quantify the level of skills on essential newborn care. The data will be collected six times. The data will be collected onsite by provincial and/or central facilitators at timepoints 1), 2), 3) and 7) (see below). The skill tests will be video recorded at each time. Assessment at three, six and nine months after the baseline will be assessed only via video recording to reduce travel burden of facilitators. Data will be collected six times for each district hospital: 1) Immediately before the refresher EENC coaching 2) Immediately after the refresher EENC coaching (baseline) 3) Three months after the baseline, 4) Six months after the baseline, 5) Nine months after the baseline, and 6) 12 months after the baseline (endline)
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Timepoint [1]
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1) Immediately before the refresher EENC coaching 2) Immediately after the refresher EENC coaching (baseline) 3) Three months after the baseline, 4) Six months after the baseline, 5) Nine months after the baseline, and 6) 12 months after the baseline (endline, primary timepoint)
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Secondary outcome [1]
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Exclusive breastfeeding rate at 7 days of birth
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Assessment method [1]
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Babies born in district hospitals and discharged alive will be followed up via mobile phone until 7 days after birth to confirm the breastfeeding status.
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Timepoint [1]
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7 days after birth.
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Secondary outcome [2]
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Composite of neonatal adverse outcomes within 7 days of birth, defined as the occurrence of one or more of the following conditions: #1 Neonatal death within 7 days of birth regardless of location OR #2 Readmission to hospital between time of discharge and 7 days of birth OR #3 Neonatal transfer to other hospitals before discharge from a hospital of birth or within 7 days of birth for newborns staying hospital OR #4 Apgar score < 7 at 5 minutes OR #5 Bag and mask ventilation before discharge from a hospital of birth or within 7 days of birth for newborns staying hospital OR #6 Oxygen use for more than 2 hours before discharge from a hospital of birth or within 7 days of birth for newborns staying hospital #7 CPAP use for more than 2 hours before discharge from a hospital of birth or within 7 days of birth for newborns staying hospital #8 Seizure before discharge from a hospital of birth or within 7 days of birth for newborns staying hospital
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Assessment method [2]
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Babies born in district hospitals and discharged alive will be followed up by mobile phone until 7 days after birth to confirm outcomes #1 and #2. Data collectors will contact each district hospital weekly to confirm newborns, their outcomes and contact details. All other data will be collected from the medical records by phone call by the data collectors.
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Timepoint [2]
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7 days after birth.
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Secondary outcome [3]
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Success rate of chest rise within 1 minute
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Assessment method [3]
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We will use a standardised simulation test, developed by WHO regional office for the Western Pacific. We will use the success rates that will be directly observed by EENC facilitators immediately before and after baseline and endline. Data will be collected three times for each district hospital: 1) Immediately before the refresher EENC coaching 2) Immediately after the refresher EENC coaching (baseline) 3) 12 months after the baseline (endline)
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Timepoint [3]
450413
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1) Immediately before the refresher EENC coaching 2) Immediately after the refresher EENC coaching (baseline) 3) 12 months after the baseline (endline),
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Secondary outcome [4]
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EENC knowledge among district healthcare providers at 12 months post coaching (knowledge score).
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Assessment method [4]
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We will use a standardised written test, developed by WHO regional office for the Western Pacific, to quantify the level of knowledge on essential newborn care. The data will be collected onsite by provincial and/or central facilitators. Data will be collected three times for each district hospital: 1) Before the refresher EENC coaching 2) Immediately after the refresher EENC coaching 3) 12 months after the baseline
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Timepoint [4]
450414
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1) Immediately before the refresher EENC coaching 2) Immediately after the refresher EENC coaching (baseline) 3) 12 months after the baseline (endline),
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Secondary outcome [5]
450415
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Fidelity of implementing the intervention
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Assessment method [5]
450415
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This will be assessed as a composite outcome, incorporating the following items: #1. Consistency of implementation across staff and time •Percent providers who perform self-practice once per month for management of a breathing baby. •Percent providers who perform self-practice once per month for management of a non-breathing baby. •Percent providers who receive feedback from facilitators for all videos. •Number of feedback comments that each facilitator made per month. #2. Average time per month spent for a self-practice session among providers. #3. Average time per month spent for providing feedback among facilitators. #4. Any adaptation made for implementing the intervention (when, what and why). #1-#3 will be collected from activity logbooks and WhatsApp log at all district and provincial hospitals. The logbooks will be recorded by a designated provider/facilitator at each site during the trial period. #4 will be collected through a structured interview at the end of the trial in all district hospitals.
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Timepoint [5]
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12 months after the baseline
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Secondary outcome [6]
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Factors influencing the implementation of the intervention.
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Assessment method [6]
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This will be assessed as a composite outcome, using quantitative and qualitative measures at the end of the trial. The quantitative measure uses a checklist to determine whether the expected changes have occurred at each facility based on the 14-item pCAT Mapping. The pCAT is designed based on the Consolidated Framework for Implementation Research (CFIR). The pCAT is initially discussed and completed in all district hospitals in the intervention arm and in provincial hospitals at baseline, and is reviewed again at endline. The qualitative measure will use a semi-structured interview with the board of directors and a focus group discussion (FGD) with providers in selected district hospitals at the end of the trial. The district hospitals will be purposively selected based on the implementation status (one each from a hospital that implemented the intervention well and poorly at each province, six district hospitals in total). A separate FGD will be conducted with provincial EENC facilitators at three provincial hospitals and central EENC facilitators. A total of 10 FGDs will be conducted. The FGD guides will be developed based on the Theoretical Domains Framework (version 2.0)16 and will be mapped against the Behaviour Change Wheel (BCW), which characterizes behaviour in terms of Capability, Opportunity, and Motivation (COM-B). Each FGD will take up to 90 minutes. FGDs will be facilitated in Laotian by a trained researcher, audio recorded, transcribed, and translated into English by an external agency.
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Timepoint [6]
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12 months after the baseline
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Secondary outcome [7]
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The mechanism of impact
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Assessment method [7]
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This will be assessed as a composite outcome. According to the theory of change, we will assess how the following items have changed during the intervention period. #1. Providers’ confidence to perform EENC #2. Providers’ willingness to perform EENC #3. Change in the norms at district hospital regarding EENC provision #4. Change in the team teamwork in EENC provision at district hospital For #1, we will conduct a quantitative survey for providers, using a Likert scale for management of breathing baby and non-breathing baby, respectively, at baseline and endline. For #2-#4, we will use a qualitative measure (FGD) with providers at the district hospitals.
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Timepoint [7]
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12 months after the baseline
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Eligibility
Key inclusion criteria
District-level healthcare providers providing newborn care in district hospitals will be recruited into the trial.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
No exclusion criteria
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The random number will be generated by a study statistician and will be concealed from the data collectors and EENC facilitators until they visit district hospitals to introduce the intervention.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random number will be generated by a study statistician and will be concealed from the data collectors and EENC facilitators until they visit district hospitals to introduce the intervention.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
All analyses will be done by intention-to-treat, which means that clusters will be analysed according to their randomised allocation. Healthcare providers baseline characteristics such as age, sex, position, experience in years will be summarised as means and standard deviations, medians and inter-quartile ranges, or numbers and percentages, as appropriate, grouped by trial arm. A trial diagram will be presented showing the outcome by cluster. To ensure that cluster randomisation is successful, the significance of differences between the intervention and control groups for the baseline characteristics of participants will be examined using chi-squared test and t-test.
Primary outcome (Skills score)
We will compare the average score of the skills score between the intervention and control groups using a linear mixed-effects model employing the maximum likelihood method adjusted for its baseline skill score. To deal with missing data, we will conduct 1) alternative mixed methods without imputation, 2) single imputation, using the last observation carried forward, and 3) multiple imputation using predictive mean matching. In the alternative mixed methods, interaction between the intervention and time (baseline and endline) will be estimated. Assumption of missing at random will be examined before applying imputations. In the multiple imputations, we will conducted 20 imputations by including the corresponding baseline value of the primary outcome and the intervention value. Sensitivity analyses will be planned to use the per protocol set (PPS). We will also perform analysis adjusted for all baseline variables.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
24/11/2025
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Actual
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Date of last participant enrolment
Anticipated
31/03/2026
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Actual
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Date of last data collection
Anticipated
31/03/2028
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
27258
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Lao People's Democratic Republic
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State/province [1]
27258
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Funding & Sponsors
Funding source category [1]
319595
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Government body
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Name [1]
319595
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Japan Society for the Promotion of Science
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Address [1]
319595
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Country [1]
319595
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Japan
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Primary sponsor type
Other
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Name
Burnet Institute
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Address
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Country
Australia
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Secondary sponsor category [1]
322098
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University
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Name [1]
322098
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University of Yamanashi
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Address [1]
322098
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Country [1]
322098
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Japan
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Other collaborator category [1]
283605
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Government body
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Name [1]
283605
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Ministry of Health
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Address [1]
283605
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Country [1]
283605
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Lao People's Democratic Republic
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Other collaborator category [2]
283606
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Government body
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Name [2]
283606
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Lao Tropical Public Health Institute
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Address [2]
283606
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Country [2]
283606
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Lao People's Democratic Republic
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Other collaborator category [3]
283607
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University
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Name [3]
283607
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Juntendo University
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Address [3]
283607
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Country [3]
283607
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Japan
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318159
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
318159
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
318159
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Australia
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Date submitted for ethics approval [1]
318159
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15/04/2025
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Approval date [1]
318159
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03/06/2025
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Ethics approval number [1]
318159
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286/25
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Ethics committee name [2]
318161
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National Ethics Committee for Health Research of the Lao People's Democratic Republic
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Ethics committee address [2]
318161
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Ban Kaoyoth, Sisattanak district, Vientiane capital, Lao PDR
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Ethics committee country [2]
318161
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Lao People's Democratic Republic
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Date submitted for ethics approval [2]
318161
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07/04/2025
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Approval date [2]
318161
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22/05/2025
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Ethics approval number [2]
318161
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2025.26
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Summary
Brief summary
A cluster-randomised controlled trial with process evaluation in 20 district hospitals in Lao PDR. The trial aims to test the effectiveness of a novel educational intervention for healthcare providers in maintaining skills in early essential newborn care and improving newborn health outcomes. The intervention has been designed to provide continuous access to learning opportunities for district healthcare providers using a low-dose, high-frequency approach (repeated short self-practice sessions), combined with access to mobile-based supportive supervision. This study will also evaluate the process of the implementation to understand how and why the intervention led to the observed effects. This study will generate evidence to support educational interventions that can improve quality of newborn care and newborn health outcomes in resource-limited settings.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Sayaka Horiuchi
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Address
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Burnet Institute 85 Commercial Rd, Melbourne VIC 3004
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Country
143302
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Australia
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Phone
143302
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+61421829124
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Fax
143302
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Email
143302
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[email protected]
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Contact person for public queries
Name
143303
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Sayaka Horiuchi
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Address
143303
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Burnet Institute 85 Commercial Rd, Melbourne VIC 3004
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Country
143303
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Australia
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Phone
143303
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+61421829124
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Fax
143303
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Email
143303
0
[email protected]
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Contact person for scientific queries
Name
143304
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Sayaka Horiuchi
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Address
143304
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Burnet Institute 85 Commercial Rd, Melbourne VIC 3004
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Country
143304
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Australia
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Phone
143304
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+61421829124
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Fax
143304
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Email
143304
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers
Conditions for requesting access:
•
Yes, conditions apply:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
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All de-identified individual participant data
What types of analyses could be done with individual participant data?
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Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
[email protected]
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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