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

NCT04904380 | Unknown

• 1 other identifier: 2020/MUST-5/SIM-II
• Study Type: interventional
• Target: 3,456
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Mortality; Maternal Mortality

Outcome Measures

Primary Outcomes (4)

• Neonatal mortality

  Neonatal mortality

  Neonatal mortality at 6 months

• Neonatal mortality

  Neonatal mortality

  Neonatal mortality at 18 months

• Maternal mortality

  Maternal mortality

  Maternal mortality at 6 months

• Maternal mortality

  Maternal mortality

  Maternal mortality at 18 months

Secondary Outcomes (2)

• Length of stay in hospital

  18 months

• Completeness of newborn assessment

  At admission

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Active peer learning

Comparison arm

ACTIVE COMPARATOR

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

Other: Active peer learning

Interventions

Active peer learning OTHER

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

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

Comparison arm; Intervention

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• University of Calgary: collaborator
• The ELMA Foundation: collaborator
• Alberta Children's Hospital Research Institute: collaborator
• Laerdal Foundation: collaborator
• International Development Research Centre, Canada: collaborator

MeSH Terms

Conditions

Maternal Death

Interventions

Hemoglobin, Sickle; Air

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemoglobins, Abnormal; Hemoglobins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Data Santorino, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Data Santorino, MD

CONTACT

0774500571; sdata@must.ac.ug

Francis Bajunirwe, MD, PhD

CONTACT

0772 576 396; fbaj@must.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cluster trial

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 27, 2021
• Study Start: October 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: May 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share