Neonatal MortalitySim-IINCT04904380
Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality
A study testing Active peer learning in people with Neonatal Mortality and Maternal Mortality, run by Mbarara University of Science and Technology.
Trial summary
In the vast majority of developing nations, frontline birth attendants are often the only care providers responsible for newborn care including newborn resuscitation, thermal care, feeding and administration of medications. These midwives need knowledge and skills to provide all these newborn clinical care needs. Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Neonatal Mortality, Maternal Mortality
- What is being tested?
- Active peer learning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,456 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 30 Dec 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 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Newborns babies
- Mothers delivering at participating health facilities
- Health workers providing maternal and newborn care services at participating health facilities
Who cannot join
- Health care workers not providing maternal and newborn care services
- Male patients
- Non pregnant female patients seeking care at participating health facilities
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Impact of Simulation-enhanced Peer Learning With Novel Tools on Maternal and Newborn Mortality Plus Knowledge, Skills Retention and Decision Making by Front-line Health Workers in Southwestern Uganda
In the vast majority of developing nations, frontline birth attendants are often the only care providers responsible for newborn care including newborn resuscitation, thermal care, feeding and administration of medications. These midwives need knowledge and skills to provide all these newborn clinical care needs. However, frontline birth attendants in these circumstances are seldom exposed to the training and decision support tools that would empower them to holistically assess, decide and manage newborn babies in their care. Current training opportunities are fragmented and need to be administered as a comprehensive package.
A combination approach to training, skills retention, and the use of decision support tools such as Protecting Infants Remotely by SMS (PRISMS) and Augmented Infant Resuscitator (AIR) may provide a comprehensive package for the acquisition and retention of knowledge and skills on newborn care and empower birth attendants to provide effective, timely interventions.
Read the detailed description
The investigators will implement the Sim for Life Impart, Retain, Empower and Monitor (IREM) module at the University of Jos teaching Hospital and 4 high volume health facilities in Tanzania in addition to the Uganda sites. We propose to implement the program with all its components for each of the partner institutions.
The Sim for Life IREM module combines four strategies: Impart skills using Helping Babies Survive (HBS)/Helping Mothers Survive (HMS) courses, Retain skills (Simulation), Empower birth attendants (PRISMS and AIR) and Monitor progress objectively. The simulation sessions for health facilities will be conducted using the peer to peer learning methodology which equips participants with the skills to facilitate simulation scenarios in their health facilities. The scenarios will be provided by the Sim for life team. The topics for the scenarios will be based on common maternal and newborn illnesses like post-partum hemorrhage, pre-eclampsia, birth asphyxia, neonatal sepsis and prematurity.
All health facilities in this study will require smart phones for the PRISMS application, resuscitation practice tables, source of electricity to charge a phone, practice manikins / associated practice supplies and peer learning cards.
- Conditions
- Neonatal Mortality, Maternal Mortality
- Being tested
- Active peer learning
- Medical subject headings
- Maternal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active peer learningOther
Also called Enhanced HMS and HBS with PRISMS and AIR
HMS, HBS and peer learning in combination with AIR and PRISMS
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | HMS, HBS and peer learning in combination with AIR and PRISMS Receives: Other: Active peer learning |
| Comparison arm | Active comparator | HMS, HBS and peer learning in combination with PRISMS but no AIR Receives: Other: Active peer learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal mortality
Neonatal mortality
Measured: Neonatal mortality at 6 months
Neonatal mortality
Neonatal mortality
Measured: Neonatal mortality at 18 months
Maternal mortality
Maternal mortality
Measured: Maternal mortality at 6 months
Maternal mortality
Maternal mortality
Measured: Maternal mortality at 18 months
Secondary outcomes (2)
Length of stay in hospital
Number of days as length of stay
Measured: 18 months
Completeness of newborn assessment
Completeness of newborn assessment checklist
Measured: At admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal MortalityStudies 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
- Randomized cluster trial
- Masking
- None (open label)
- Enrolment
- 3,456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mbarara University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation, International Development Research Centre, Canada
- Responsible party
- Sponsor
- Investigators
- Data Santorino, MD, Principal investigator, Mbarara University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904380
- Sponsor's protocol ID
- 2020/MUST-5/SIM-II
- Acronym
- Sim-II
- Status last verified
- Apr 2021
- First submitted
- 30 Apr 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data includes sensitive material with video records
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Simulation-enhanced Peer Learning With Novel Tools on Maternal and Newborn Mortality Plus Knowledge, Skills Retention and Decision Making by Front-line Health Workers in Southwestern Uganda
- ClinicalTrials.gov ID
- NCT04904380
- Acronym / sponsor ID
- Sim-II / 2020/MUST-5/SIM-II
- Conditions
- Neonatal Mortality, Maternal Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,456 participants (estimated)
- Lead sponsor
- Mbarara University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation, International Development Research Centre, Canada
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 May 2021 (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.
In the vast majority of developing nations, frontline birth attendants are often the only care providers responsible for newborn care including newborn resuscitation, thermal care, feeding and administration of medications. These midwives need knowledge and skills to provide all these newborn clinical care needs. However, frontline birth attendants in these circumstances are seldom exposed to the training and decision support tools that would empower them to holistically assess, decide and manage newborn babies in their care. Current training opportunities are fragmented and need to be administered as a comprehensive package.
A combination approach to training, skills retention, and the use of decision support tools such as Protecting Infants Remotely by SMS (PRISMS) and Augmented Infant Resuscitator (AIR) may provide a comprehensive package for the acquisition and retention of knowledge and skills on newborn care and empower birth attendants to provide effective, timely interventions.
Detailed description
The investigators will implement the Sim for Life Impart, Retain, Empower and Monitor (IREM) module at the University of Jos teaching Hospital and 4 high volume health facilities in Tanzania in addition to the Uganda sites. We propose to implement the program with all its components for each of the partner institutions.
The Sim for Life IREM module combines four strategies: Impart skills using Helping Babies Survive (HBS)/Helping Mothers Survive (HMS) courses, Retain skills (Simulation), Empower birth attendants (PRISMS and AIR) and Monitor progress objectively. The simulation sessions for health facilities will be conducted using the peer to peer learning methodology which equips participants with the skills to facilitate simulation scenarios in their health facilities. The scenarios will be provided by the Sim for life team. The topics for the scenarios will be based on common maternal and newborn illnesses like post-partum hemorrhage, pre-eclampsia, birth asphyxia, neonatal sepsis and prematurity.
All health facilities in this study will require smart phones for the PRISMS application, resuscitation practice tables, source of electricity to charge a phone, practice manikins / associated practice supplies and peer learning cards.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cluster trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Active peer learningHMS, HBS and peer learning in combination with AIR and PRISMS |
| Comparison arm | Active comparator | Other: Active peer learningHMS, HBS and peer learning in combination with PRISMS but no AIR |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Newborns babies
- Mothers delivering at participating health facilities
- Health workers providing maternal and newborn care services at participating health facilities
Key exclusion criteria (3 listed)
- Health care workers not providing maternal and newborn care services
- Male patients
- Non pregnant female patients seeking care at participating health facilities
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 |
|---|---|---|
| Active peer learningAlso: Enhanced HMS and HBS with PRISMS and AIRHMS, HBS and peer learning in combination with AIR and PRISMS | Other | Comparison arm, Intervention |
Primary outcome
Neonatal mortality
Time frame: Neonatal mortality at 6 months
Neonatal mortality
Neonatal mortality
Time frame: Neonatal mortality at 18 months
Neonatal mortality
Maternal mortality
Time frame: Maternal mortality at 6 months
Maternal mortality
Maternal mortality
Time frame: Maternal mortality at 18 months
Maternal mortality
2 secondary outcomes
Length of stay in hospital
Time frame: 18 months
Completeness of newborn assessment
Time frame: At admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Individual participant dataSharing planned: No. Data includes sensitive material with video records
Related trials for Neonatal Mortality
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Accelerating Maternal and Newborn Survival: The AMANI Study
Maternal and Perinatal Death Surveillance and Response (MPDSR) Implementation, Maternal Mortality
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
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Clean Trial - Chlorination to Reduce Enteric and Antibiotic Resistant Infections in Neonates
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Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
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Predictors of Outcomes in Pulmonary Hypertension of the Newborn
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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.
Data Santorino, MD principal investigator
Mbarara University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Active peer learning in people with Neonatal Mortality and Maternal Mortality, run by Mbarara University of Science and Technology.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Data Santorino, MD (0774500571, sdata@must.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal mortality (time frame: Neonatal mortality at 6 months). The study lists 4 primary outcomes in all. 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 27 May 2021.