Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
The Airway, Breathing, Circulation, Disability, and Exposure (ABCDE) approach is widely recommended and taught in many resuscitation courses. In this study we assess the adherence to the ABCDE algorithm and whether this is affected by the instruction method used to teach this approach in healthcare professionals who work with new born babies (neonates).

Who can participate?
Neonatal healthcare providers (nurses, ward physicians, and consultants) of all ages, employed at the Radboudumc, Nijmegen, the Netherlands.

What does the study involve?
Performing neonatal advanced life support (NALS) scenarios on a manikin and determining to what extent the professionals follow the ABCDE approach during such simulated resuscitations, and whether or not the adherence to the ABCDE structure differs between professionals who are trained regarding the ABCDE structure by means of a lecture or through a video-based instruction.

What are the benefits and risks of participating?
There are no risks involved in this study. The benefit for the partaking professionals may be that they are better trained in the ABCDE approach by one of the two instructional methods.

Where is the study run from?
The simulation facility of the tertiary care perinatal center (Radboudumc, Nijmegen, the Netherlands).

When is the study starting and how long is it expected to run for?
May 2017 to January 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Mathijs Binkhorst,

Trial website

Contact information



Primary contact

Mr Mathijs Binkhorst


Contact details

Geert Grooteplein-Zuid 10
6525 GA
+31 651225283

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Adherence to the ABCDE approach in relation to the method of instruction: a randomized controlled simulation study



Study hypothesis

We want to investigate to what extent neonatal healthcare professionals follow or adhere to the ABCDE structure (also referred to as ABCDE approach or algorithm) during simulated neonatal advanced life support (NALS) scenarios. In addition, we want to determine whether this adherence is different between professionals trained in this strcuture by means of a lecture or through video-based instruction (VBI).

Ethics approval

Approved 19/06/2017, Institutional Review Board (IRB) of the Radboud UMC (Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, the Netherlands; +31-24-3613154;, ref: 2017-3513

Study design

Single-center single-blinded randomized controlled simulation study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

No participant information sheet available


Adherence to guideline among neonatal healthcare professionals during the simulated resuscitation of newborns.


Participants are randomly assigned to the two study groups, using sequentially numbered opaque sealed envelopes by an independent third party, with an allocation ratio of 1:1.
One group of professionals receives training/instruction regarding the ABCDE algorithm by means of a conventional (PowerPoint) lecture (20-30 min in duration, provided by an experienced simulation specialist).
The other group receives a video-based instruction (15 min, video specifically recorded for this study, showing peer professionals performing the ABCDE approach, just like the lecture only available on study days, not online or elsewhere).

All participants then perform neonatal advanced life support scenarios in the simulation facility of our tertiary perinatal care center (Radboudumc, Nijmegen, the Netherlands). During these scenarios, they systematically evaluate the condition of simulated, vitally unstable neonatal patients using the ABCDE structure. All scenarios are videotaped for later ananlysis.

Intervention type



Drug names

Primary outcome measure

Adherence to the ABCDE structure/approach is measured by a specifically trained video observer with an assessment instrument/scoring list, which was specifically developed and validated for this study. This video-based scoring procedure takes place several weeks after the scenarios are performed.

Secondary outcome measures

1. Adherence of each profession category (nurses, ward physicians, fellows/neonatologists) to the ABCDE approach, measured using the abovementioned assessment instrument, at the same time point (several weeks after the actual scenarios)
2. Adherence to the domains (A, B, C, D, E) of the ABCDE approach, measured using the abovementioned assessment instrument, at the same time point (several weeks after the actual scenarios)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Neonatal healthcare professionals of all ages, working at the neonatal intensive care unit (NICU) and/or high care (HC) of the Radboudumc, Nijmegen, the Netherlands

Participant type

Health professional

Age group




Target number of participants

Based on a sample size estimation, the target total number of participants was 42 (21 per group)

Total final enrolment


Participant exclusion criteria

Participant refuses to give permission to use his/her videotaped scenarios for study purposes

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Radboud University Medical Center Amalia Children's Hospital
Geert Grooteplein-Zuid 10
6525 GA

Sponsor information


Amalia Kinderziekenhuis

Sponsor details

Geert Grooteplein-Zuid 10
6525 GA
+31 243614430

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Planned publication in a journal for the target audience (i.e. resuscitation of medical education journal). All data generated in this study will be incorporated in the manuscript.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

Not applicable.

Publication citations

Additional files

Editorial Notes

12/10/2020: Trial's existence confirmed by Radboud University Nijmegen Medical Centre Research Ethics Committee.