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Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality (Sim-II)

Primary Purpose

Neonatal Mortality, Maternal Mortality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Active peer learning
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neonatal Mortality

Eligibility Criteria

0 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Comparison arm

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Neonatal mortality
    Neonatal mortality
    Neonatal mortality
    Neonatal mortality
    Maternal mortality
    Maternal mortality
    Maternal mortality
    Maternal mortality

    Secondary Outcome Measures

    Length of stay in hospital
    Number of days as length of stay
    Completeness of newborn assessment
    Completeness of newborn assessment checklist

    Full Information

    First Posted
    April 30, 2021
    Last Updated
    May 26, 2021
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04904380
    Brief Title
    Impact of New Tools of Simulation-enhanced Peer Learning on Neonatal and Maternal Mortality
    Acronym
    Sim-II
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    December 30, 2022 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the 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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neonatal Mortality, Maternal Mortality

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized cluster trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3456 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    HMS, HBS and peer learning in combination with AIR and PRISMS
    Arm Title
    Comparison arm
    Arm Type
    Active Comparator
    Arm Description
    HMS, HBS and peer learning in combination with PRISMS but no AIR
    Intervention Type
    Other
    Intervention Name(s)
    Active peer learning
    Other Intervention Name(s)
    Enhanced HMS and HBS with PRISMS and AIR
    Intervention Description
    HMS, HBS and peer learning in combination with AIR and PRISMS
    Primary Outcome Measure Information:
    Title
    Neonatal mortality
    Description
    Neonatal mortality
    Time Frame
    Neonatal mortality at 6 months
    Title
    Neonatal mortality
    Description
    Neonatal mortality
    Time Frame
    Neonatal mortality at 18 months
    Title
    Maternal mortality
    Description
    Maternal mortality
    Time Frame
    Maternal mortality at 6 months
    Title
    Maternal mortality
    Description
    Maternal mortality
    Time Frame
    Maternal mortality at 18 months
    Secondary Outcome Measure Information:
    Title
    Length of stay in hospital
    Description
    Number of days as length of stay
    Time Frame
    18 months
    Title
    Completeness of newborn assessment
    Description
    Completeness of newborn assessment checklist
    Time Frame
    At admission

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Newborns babies Mothers delivering at participating health facilities Health workers providing maternal and newborn care services at participating health facilities Exclusion Criteria: Health care workers not providing maternal and newborn care services Male patients Non pregnant female patients seeking care at participating health facilities
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Data Santorino, MD
    Phone
    0774500571
    Email
    sdata@must.ac.ug
    First Name & Middle Initial & Last Name or Official Title & Degree
    Francis Bajunirwe, MD, PhD
    Phone
    0772 576 396
    Email
    fbaj@must.ac.ug
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Data Santorino, MD
    Organizational Affiliation
    Mbarara University of Science and Technology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data includes sensitive material with video records

    Learn more about this trial

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

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