Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202210665523687 Date of Approval: 31/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Checklist based briefing and online video-assisted debriefing on Neonatal resuscitation practices and outcomes in Ethiopia: Randomized Controlled Trial
Official scientific title Effects of Checklist based briefing and online video-assisted debriefing on Neonatal resuscitation practices and outcomes in Ethiopia: Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Background: Briefing and debriefing are methods used by professionals to reduce the overall risk to life and enhance the safety of the human beings involved in receiving and delivering the services provided. Evidence gathered around the effect of briefing and debriefing after resuscitation is also encouraging. Implementation and effectiveness of a video-based debriefing program for neonatal resuscitation showed an improved task score from 77% to 89%. However, the effect of briefing and debriefing on care systems in low resources settings is not yet well examined. Objectives: To investigate the effects of checklist-based briefing and online video-assisted debriefing on neonatal resuscitation practices and outcomes in Ethiopia. Methods: Hospital-level randomized control trial (RCT) will be employed. A total of 400 deliveries conducted by birth attendants who are working in eight selected hospitals found in West Shewa Zone, Ethiopia will be included in the study. Birth attendants in both control and interventional groups will receive refresher Helping babies breath training and the interventional group will receive briefing and debriefing training, furthermore, the debriefing will be assisted using a weekly video meeting with experts for a month duration. We will apply blinding during data collection in this study to minimize bias. The baseline data will be collected using secondary data using a patient chart review and an observational checklist prepared electronically using CSPRO Version 7.6 will be used to collect data for observing the birth attendants' practice. The collected data will be exported to SPSS version 25 for analysis. Descriptive statistics including graphs, and tables will be used to describe the data. An Independent sample t-test will be used to test the statistical difference in the mean competency performance between interventions and control groups.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 28/10/2022
Actual trial start date
Anticipated date of last follow up 05/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group briefing and debriefing training Five times One Month • First, we will provide refresher training on HBB for all birth attendants working for both control and intervention hospitals. The American Academy of Pediatrics HBB 2nd Edition materials – Action Plan, Facilitator Flip Chart, and Provider Guide will be used to provide the refresher training. • Secondly, the birth attendants at the intervention hospitals will receive briefing and debriefing training. The briefing and debriefing training guide will be prepared based on the scoping review on the Use of briefing and debriefing in neonatal resuscitation, the HBB 2nd Edition Facilitator Flip Chart, and other relevant literature. The training guide will be examined and validated by educational design experts, pediatricians, midwives, and obstetricians. • Thirdly: the intervention group will have a weekly online video-assisted debriefing for the one-month duration with the team of investigators. The intervention group will be provided tablets with an internet package. The online video-based debriefing may last about forty-five minutes to one-hour duration depending on the circumstances of each interventional hospital. During the video-assisted debriefing, the birth attendants in the intervention group will be debriefed by pediatricians virtually on the issues related to neonatal resuscitation they provided; on what went well, what went wrong, and how it can be corrected. 200
Control Group refresher training on HBB Once three days we will provide refresher training on HBB for all birth attendants working for both control and intervention hospitals. The American Academy of Pediatrics HBB 2nd Edition materials – Action Plan, Facilitator Flip Chart, and Provider Guide will be used to provide the refresher training. 200 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All birth attendants who are working in public hospitals found in West Shewa Zone, Oromia Region, Ethiopia Teaching Hospitals Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/10/2022 Ambo University College of Medicine and Health Sciences Research Ethical Review Board
Ethics Committee Address
Street address City Postal code Country
A4 Ambo 0019 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Task execution of birth attendants Data will be collected from both control and interention groups regarding baseline data on neonatal outcome before the training and the observational data collection will be started within one months
Secondary Outcome Neonatal outcomes, i.e Fifth minute APGAR score and neonatal survival status Data will be collected from both control and interention groups regarding baseline data on neonatal outcome before the training and the observational data collection will be started within one months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ambo University A4 Ambo 0019 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
laerdal foundation 4003 Stavanger 556 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Laerdal Foundation 4003 Stavanger 556 Norway Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Benyam Seifu benyamseifu77@gmail.com +251910451184 A4
City Postal code Country Position/Affiliation
Ambo 0019 Ethiopia Assistant Professor
Role Name Email Phone Street address
Scientific Enquiries Gizachew Abdissa gizachew.abdissa@ambou.edu.et +251913283308 A4
City Postal code Country Position/Affiliation
Ambo 0019 Ethiopia Assistant Professor
Role Name Email Phone Street address
Public Enquiries GETU DEMISSE getualemu103@gmail.com +251910475264 A4
City Postal code Country Position/Affiliation
Ambo 0019 Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 6 months and ending 12 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information