ClinicalTrials.gg
Status unknownNCT04904380Sim-IIUpdated May 27, 2021

Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality

An interventional study of Active peer learning in Neonatal Mortality and Maternal Mortality, sponsored by Mbarara University of Science and Technology. Status unknown. Open to participants aged 0 Days and older. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Mbarara University of Science and Technology · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3,456
Allocation
Randomized
Ages
0 Days and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Neonatal Mortality
  • Maternal Mortality

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03

In context

Maternal Death

77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.

This study's planned enrollment of 3,456 is above the median of 1,126 across 57 interventional studies indexed under Maternal Death.

Browse Maternal Death studies →

Lead sponsor

Mbarara University of Science and Technology is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Newborns babies
  • Mothers delivering at participating health facilities
  • Health workers providing maternal and newborn care services at participating health facilities

Exclusion criteria

Exclusion Criteria:

  • Health care workers not providing maternal and newborn care services
  • Male patients
  • Non pregnant female patients seeking care at participating health facilities
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,456 participants (estimated)

Study arms

  • Experimental
    Intervention

    HMS, HBS and peer learning in combination with AIR and PRISMS

    Other: Active peer learning

  • Active comparator
    Comparison arm

    HMS, HBS and peer learning in combination with PRISMS but no AIR

    Other: Active peer learning

Interventions

  • OtherActive peer learning

    HMS, HBS and peer learning in combination with AIR and PRISMS

    Also known as: Enhanced HMS and HBS with PRISMS and AIR

06

What researchers measure

Primary outcomes

  1. Neonatal mortality

    Neonatal mortality

    Time frame: Neonatal mortality at 6 months

  2. Neonatal mortality

    Neonatal mortality

    Time frame: Neonatal mortality at 18 months

  3. Maternal mortality

    Maternal mortality

    Time frame: Maternal mortality at 6 months

  4. Maternal mortality

    Maternal mortality

    Time frame: Maternal mortality at 18 months

Secondary outcomes

  1. Length of stay in hospital

    Number of days as length of stay

    Time frame: 18 months

  2. Completeness of newborn assessment

    Completeness of newborn assessment checklist

    Time frame: At admission

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Data includes sensitive material with video records

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2021; primary completion for Dec 2022, 14 months later.

Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's planned 14 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2021
First posted
May 27, 2021
StartEst.
Oct 1, 2021
Primary completionEst.
Dec 30, 2022
CompletionEst.
Dec 30, 2023
Last update
May 27, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04904380
Lead sponsor
Mbarara University of Science and Technology
Collaborators
University of Calgary, The ELMA Foundation, Alberta Children's Hospital Research Institute, Laerdal Foundation, International Development Research Centre, Canada
Responsible party
Sponsor
First posted
May 27, 2021
Start date
Oct 1, 2021 (estimated)
Primary completion
Dec 30, 2022 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
May 27, 2021

Study contacts

Data Santorino, MD
Contact
sdata@must.ac.ug
0774500571
Francis Bajunirwe, MD, PhD
Contact
fbaj@must.ac.ug
0772 576 396
Data Santorino, MD
principal investigator · Mbarara University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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