Newborn MorbiditySaLiNNCT06213207
Cluster Randomized Controlled Trial Applying Helping Baby Breathe in Nepal
A study testing Simulator based training to manage asphyxia and essential newborn care using neonatalie in people with Newborn Morbidity and Newborn Asphyxia, run by Integrated Development Foundation Nepal at 1 site in Nepal.
Trial summary
The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities. The investigators will assess the newborn in terms of their health outcomes. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Newborn Morbidity, Newborn Asphyxia, Delivery Preterm
- What is being tested?
- Simulator based training to manage asphyxia and essential newborn care using neonatalie
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteNepal
- Study dates
- 18 Feb 2024to 31 Dec 2025
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Health service providers those are directly involved in providing newborn care services
- Have received Community-based Integrated Management of Neonatal and Childhood Illness (CB-IMNCI) training Have worked in the study facilities at least one year
Who cannot join
- Health workers, Those lack experience at least six months of working in birthing centers Those who does not qualify as skilled birth attendant (non-SBA) Those who received training already
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Saving Lives of Newborn (SaLiN): A Cluster Randomized Controlled Trial Applying Helping Baby Breathe to Manage Birth Asphyxia in Sarlahi District of Madhesh Province, Nepal
The cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities. The investigators will assess the newborn in terms of their health outcomes. Characteristics related to the performance of skilled birth attendants will be measured prior to the intervention. After six months of the intervention, endline assessment will be conducted. The intervention unit are the health facilities which provide the services as birthing centers. The effectiveness of the intervention will be examined using generalized estimating equation against baseline vs. endline on skills performance of the health workers and newborn health outcomes. The study will be implied in the similar settings to improve the skill performance and newborn health outcomes in order to reduce neonatal mortality.
Read the detailed description
In Nepal, health facilities need to be strengthened and the staff should be tailored training at health facilities who are designated as birthing center. Although, the health facility readiness survey has shown that health facilities had availability of bag and mask (neonatal) neonatal resuscitation equipment in delivery room (Kc et al., 2020). However, health workers were found to have lack of adequate knowledge on basic emergency and neonatal care (BEmONC) signal function including poor knowledge and skill on newborn resuscitation. resulting in poor child health outcomes during facility-births and had poor knowledge and skill on newborn resuscitation (Lama et al., 2020). Newborn resuscitation simulation training was effective in improving clinical performance of health service providers and perinatal outcomes (Vadla, Moshiro, et al., 2022). NeoNatalie™ is a low-cost, highly portable, and realistic manikin that helps health workers learn and practice standard newborn care and resuscitation measures to better handle birth asphyxia(Laerdal helping save lives, 2022). Use of NeoNatalie, a newborn simulator for neonatal resuscitation training has improved performance of midwives and their motivation(Vadla, Mdoe, et al., 2022). There has been intervention that provided training on helping baby breathe (HBB) in large hospitals in Nepal. However, the use of simulator and training to the midwives at birthing center has not been evaluated for the effectiveness of simulator in increasing their performance and newborn health outcomes. Therefore, this study aimed to improve the performance of skilled-birth attendant in providing resuscitation to the newborn with birth asphyxia by applying simulator-based training.
- Conditions
- Newborn Morbidity, Newborn Asphyxia, Delivery Preterm
- Being tested
- Simulator based training to manage asphyxia and essential newborn care using neonatalie
- Keywords
- Skilled birth attendant, Management of newborn asphyxia, Neonatalie, Cluster Randomized Controlled Trial, Nepal
- Medical subject headings
- Asphyxia Neonatorum, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulator based training to manage asphyxia and essential newborn care using neonatalieOther
The intervention, HBB training package will be used which was applied to train the hospitals staff in Nepal (Chaulagain et al., 2021) and Laerdal Global Health (Laerdal Global Health, 2021) to enhance the competencies on the resuscitation to newborn using NeoNatalie. Health workers will receive 5 days simulation training by expert pediatrician and pediatric nurse who have prior working experience in Neonatal Intensive Care Unit (NICU) or Special Neonatal Care Unit. After the training, mentoring and coaching will be provided experienced newborn coach/trainer on a monthly basis for six months.
| Study group | Role | What they receive |
|---|---|---|
| Newborn care service providers with simulation-based training and newborns | Experimental | Newborn care providers will be the subject for receiving intervention. The will receive 5 days training on managing essential newborn care and birth asphyxia using neonatalie. The service providers will be provided monthly mentoring and coaching. The newborn who receive the services Receives: Other: Simulator based training to manage asphyxia and essential newborn care using neonatalie |
| Controlled health facilities with newborn care service providers with no training and newborns | No intervention | The newborn care providers from control health facilities will not receive any additional training. They provide usual services. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skill performance of the newborn care provider
The skill performance of the newborn care providers covering all nine components of essential newborn care. Their skills related to resuscitation procedures will be measured using skill inventory.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start18 Feb 2024
- Primary completion28 Feb 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn MorbidityStudies of the same condition, open and under way.
- 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
- Model description
- The intervention is targeted to provide simulator based training to newborn care service providers. The training is comprised of essential newborn care practices and the providers will be followed up and provided mentoring and coaching for the period of six months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrated Development Foundation Nepal
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children Welfare Society Nepal
- Responsible party
- Principal investigator, Khem Pokhrel, Integrated Development Foundation Nepal
- Investigators
- Santosh Adhikari, MD, Study chair, Kanti Children's Hospital, Kathmandu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213207
- Sponsor's protocol ID
- NP593-2023
- Other IDs
- 2023-0091
- Acronym
- SaLiN
- Status last verified
- Apr 2026
- First submitted
- 29 Dec 2023
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saving Lives of Newborn (SaLiN): A Cluster Randomized Controlled Trial Applying Helping Baby Breathe to Manage Birth Asphyxia in Sarlahi District of Madhesh Province, Nepal
- ClinicalTrials.gov ID
- NCT06213207
- Acronym / sponsor ID
- SaLiN / NP593-2023
- Conditions
- Newborn Morbidity, Newborn Asphyxia, Delivery Preterm
- Keywords
- Skilled birth attendant, Management of newborn asphyxia, Neonatalie, Cluster Randomized Controlled Trial, Nepal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Integrated Development Foundation NepalUniversity, hospital or other
- Collaborators
- Women and Children Welfare Society Nepal
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 19 Jan 2024 (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 cluster randomized controlled trial will be conducted in the selected health facilities/birthing centers of Sarlahi district in Nepal. Further from the selected health facilities. The investigators will assess the newborn in terms of their health outcomes. Characteristics related to the performance of skilled birth attendants will be measured prior to the intervention. After six months of the intervention, endline assessment will be conducted. The intervention unit are the health facilities which provide the services as birthing centers. The effectiveness of the intervention will be examined using generalized estimating equation against baseline vs. endline on skills performance of the health workers and newborn health outcomes. The study will be implied in the similar settings to improve the skill performance and newborn health outcomes in order to reduce neonatal mortality.
Detailed description
In Nepal, health facilities need to be strengthened and the staff should be tailored training at health facilities who are designated as birthing center. Although, the health facility readiness survey has shown that health facilities had availability of bag and mask (neonatal) neonatal resuscitation equipment in delivery room (Kc et al., 2020). However, health workers were found to have lack of adequate knowledge on basic emergency and neonatal care (BEmONC) signal function including poor knowledge and skill on newborn resuscitation. resulting in poor child health outcomes during facility-births and had poor knowledge and skill on newborn resuscitation (Lama et al., 2020). Newborn resuscitation simulation training was effective in improving clinical performance of health service providers and perinatal outcomes (Vadla, Moshiro, et al., 2022). NeoNatalie™ is a low-cost, highly portable, and realistic manikin that helps health workers learn and practice standard newborn care and resuscitation measures to better handle birth asphyxia(Laerdal helping save lives, 2022). Use of NeoNatalie, a newborn simulator for neonatal resuscitation training has improved performance of midwives and their motivation(Vadla, Mdoe, et al., 2022). There has been intervention that provided training on helping baby breathe (HBB) in large hospitals in Nepal. However, the use of simulator and training to the midwives at birthing center has not been evaluated for the effectiveness of simulator in increasing their performance and newborn health outcomes. Therefore, this study aimed to improve the performance of skilled-birth attendant in providing resuscitation to the newborn with birth asphyxia by applying simulator-based training.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention is targeted to provide simulator based training to newborn care service providers. The training is comprised of essential newborn care practices and the providers will be followed up and provided mentoring and coaching for the period of six months.
| Arm | Type | Receives |
|---|---|---|
| Newborn care service providers with simulation-based training and newborns | Experimental | Other: Simulator based training to manage asphyxia and essential newborn care using neonatalieNewborn care providers will be the subject for receiving intervention. The will receive 5 days training on managing essential newborn care and birth asphyxia using neonatalie. The service providers will be provided monthly mentoring and coaching. The newborn who receive the services |
| Controlled health facilities with newborn care service providers with no training and newborns | No intervention | –The newborn care providers from control health facilities will not receive any additional training. They provide usual services. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Health service providers those are directly involved in providing newborn care services
- Have received Community-based Integrated Management of Neonatal and Childhood Illness (CB-IMNCI) training Have worked in the study facilities at least one year
Key exclusion criteria (1 listed)
- Health workers, Those lack experience at least six months of working in birthing centers Those who does not qualify as skilled birth attendant (non-SBA) Those who received training already
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 |
|---|---|---|
| Simulator based training to manage asphyxia and essential newborn care using neonatalieThe intervention, HBB training package will be used which was applied to train the hospitals staff in Nepal (Chaulagain et al., 2021) and Laerdal Global Health (Laerdal Global Health, 2021) to enhance the competencies on the resuscitation to newborn using NeoNatalie. Health workers will receive 5 days simulation training by expert pediatrician and pediatric nurse who have prior working experience in Neonatal Intensive Care Unit (NICU) or Special Neonatal Care Unit. After the training, mentoring and coaching will be provided experienced newborn coach/trainer on a monthly basis for six months. | Other | Newborn care service providers with simulation-based training and newborns |
Primary outcome
Skill performance of the newborn care provider
Time frame: six months
The skill performance of the newborn care providers covering all nine components of essential newborn care. Their skills related to resuscitation procedures will be measured using skill inventory.
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 30 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Santosh Adhikari, MD study chair
Kanti Children's Hospital, Kathmandu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulator based training to manage asphyxia and essential newborn care using neonatalie in people with Newborn Morbidity and Newborn Asphyxia, run by Integrated Development Foundation Nepal at 1 site in Nepal.
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 2 inclusion and 1 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 30 Apr 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 Nepal. 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. 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?
Skill performance of the newborn care provider (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.