NCT03256591

Brief Summary

Helping Babies Breathe (HBB) implementation is associated with reduction in neonatal deaths and reduction in fresh stillbirths. HBB has successfully integrated some aspects of simulation into an educational curriculum that teach the management of neonatal emergencies in resource-constrained countries. Simulation based training brings special advantages and may enhance HBB training. Critical elements of simulation such as enhanced realism and post-event debriefing may carry potential to strengthen HBB training to attain maximum impact. However, evidence for the effectiveness of this combined approach is limited.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 17, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

August 15, 2017

Last Update Submit

April 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knowledge

    The primary outcome for this analysis is level of knowledge. For each course, learners will be assessed at baseline and at course-end to determine their knowledge via multiple choice test. Scores out of 100% will be computed

    Change in knowledge scores at 6 months from Baseline

Secondary Outcomes (2)

  • Clinical skills

    Change in clinical skills at 6 months from baseline

  • Facilitator debriefing skills

    Change in facilitator skills at 6 months from baseline

Study Arms (2)

HBB plus simulation training

EXPERIMENTAL

Participants receive training from facilitators for HBB training with simulation skills

Other: HBB facilitators with simulation training

Control

NO INTERVENTION

Participants receive training from facilitators for HBB training without simulation skills

Interventions

HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills

HBB plus simulation training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Only trained facilitators are eligible to participate
  • Must hold a Faculty position or are a health care provider at KIU Teaching Hospital in western Uganda
  • Are engaged in teaching health students.
  • Participating medical students are those enrolled at KIU Teaching Hospital in western Uganda

You may not qualify if:

  • Faculty and hospital workers who are not engaged in teaching health students.
  • Medical students not enrolled at KIU Teaching Hospital, western Uganda

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kampala International University

Ishaka, Bushenyi, 256, Uganda

RECRUITING

Study Officials

  • Santorini Data, MD

    Mbarara University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Santorini Data, MD

CONTACT

Francis Bajunirwe, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be done
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Investigators will conduct a prospective, randomized controlled trial to determine if the implementation of a simulation facilitator training program for HBB compared with no facilitator training in simulation is superior in terms of the acquisition of knowledge, acute care skills, and teamwork skills of pre-service medical students. Investigators will randomly randomly assign study participants to either intervention or control arm in a 1:1 ratio.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 22, 2017

Study Start

October 30, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2020

Last Updated

April 17, 2018

Record last verified: 2018-03

Locations