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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202401902880154 Date of Registration: 04/01/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Mobile Assisted Birth Asphyxia Anticipation
Official scientific title Effectiveness of Mobile Assisted Birth Asphyxia Anticipation to Enhance the Execution of Helping Babies Breathe Practice among Birth Attendants in Ethiopia: Cluster Randomized Control Trial
Brief summary describing the background and objectives of the trial Ethiopia ranks 4th with the highest neonatal death in 2020 and birth asphyxia was the leading cause, accounting for 31.6% of global mortality. Hence, preventing and early diagnosis of perinatal asphyxia is crucial for newborn survival, allowing for targeted prevention and personalized treatments, as emphasized by the 2005 American Heart Association guidelines. Helping Babies Breathe (HBB) teaches neonatal resuscitation skills, supports 99% of newborns, and reduces neonatal deaths provided that the ILCOR Formula for Survival (i.e., emphasizes sound resuscitation science guidelines, provider education, and timely implementation) is met. Skilled birth attendants can balance responsibility and vulnerability during resuscitation events using technology, like mobile-assisted birth asphyxia predictions. Therefore, this research intends to improve newborn resuscitation and survival using technology interventions to reduce delays by detecting birth asphyxia early. To do so, this project will first identify predictors of birth asphyxia using a systematic review and meta-analysis. Thus, a risk score will be created and used as supporting data to create a mobile application that uses the mother's ANC, intrapartum, and newborn parameters to predict perinatal asphyxia. Skilled birth attendants in the control and intervention hospitals receive educational interventions; skilled birth attendants in the intervention hospital will receive mobile-assisted birth asphyxia anticipation application additionally. The effect of the mobile-assisted birth asphyxia anticipation application on enhancing birth attendants' resuscitation techniques and improving neonatal outcomes will be determined and compared with the control hospitals. In general, this RCT will examine the effectiveness of mobile-assisted birth asphyxia anticipation application to improve the execution of helping baby’s breath (HBB) practice among skilled birth attendants and neonatal outcomes in Addis Ababa.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/02/2024
Actual trial start date 01/02/2024
Anticipated date of last follow up 01/07/2024
Actual Last follow-up date 01/07/2024
Anticipated target sample size (number of participants) 298
Actual target sample size (number of participants) 298
Recruitment status Active, not 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 by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Helping Babies Breath once Six Month A refresher training will be provided on HBB for all birth attendants working in 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. 149 Placebo
Experimental Group Mobile assisted Birth Asphexia anticipation once Six month First refresher training will be provided on HBB for all birth attendants working in 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. The birth attendants at the intervention hospitals will receive training on how to use the birth asphyxia anticipation android application and how to act accordingly based on the output or the suggestion of the application. Furthermore, one onsite mentor will be assigned for each intervention hospital to assist them in applying the application in the actual clinical setup. The intervention will be implemented for six months. Education design experts examine the training guide, and the training guide will be accredited. 149
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Skilled birth attendants working at Hospitals in Addis Ababa. Skilled birth attendants working at Hospitals in Addis Ababa that are not administered by Addis Ababa health bureau. Adult: 18 Year(s)-44 Year(s) 15 Year(s) 49 Year(s) Female
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 07/12/2023 Ethiopian Midwives Association Institutional Research ethics review board office
Ethics Committee Address
Street address City Postal code Country
Equatorial Guinnea Road, Near Lem hotel Addis Ababa 1410 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The effectiveness of mobile-assisted birth asphyxia anticipation: The degree to which the birth asphyxia anticipation Android application accurately and effectively predicts birth asphyxia before the infant is born is referred to as its effectiveness. It will be assessed by recording the anticipated outcome and contrasting it with the breathing status of the infant upon birth. The application will be marked as Yes (1) if the prediction is accurate; otherwise, it will be marked as No (0). At Birth
Secondary Outcome HBB practice or Task execution: The data collectors observe birth attendants' preparation for resuscitation (HBB), the timing of golden minute care provided, the birth attendants identifying and calling for help, and the overall practice of HBB. The steps of HBB practice will be observed using Objective Structured Clinical Evaluation (OSCE), and Bag-Mask Ventilation (BMV). The cut-off point for ‘pass’ and ‘fail’ was adopted from previous studies. We will compare the proportion of HBB practice between the intervention and control groups. After Birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ethiopian Midwives Association Equatorial Guinnea Road, Near Lem hotel Addis Ababa 1410 Ethiopia
Yeka Kotebe General Hospital Kotebe Addis Ababa 1000 Ethiopia
Gandhi Memorial Hospital Ras Desta Damtew St, Addis Ababa Addis Ababa 1000 Ethiopia
Tirunesh Beijing General Hospital Akaki Addis Ababa 1230 Ethiopia
Menelik II Hospital Menelik II Hospital, Menelik II Ave Addis Ababa 1000 Ethiopia
Ras Desta Referal Hospital Arbegoych St Addis Ababa 1000 Ethiopia
St. Peter Referral Hospital Intoto St, Addis Ababa Addis Ababa 1000 Ethiopia
Zewditu Memorial Hospital Ras Desta Dametew St Addis Ababa 1000 Ethiopia
Yekatit 12 Hospital Sidist Kilo, Addis Ababa Addis Ababa 1000 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 Kasiye Shiferaw sifkas.gem2@gmail.com +251913575392 Kebele 17
City Postal code Country Position/Affiliation
Harar 235 Ethiopia Assistant Professor of Public Health at Haramaya University
Role Name Email Phone Street address
Public Enquiries Benyam Seifu benyamseifu77@gmail.com +251910451184 Hayahulet
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Ambo University
Role Name Email Phone Street address
Scientific Enquiries Mulugeta Dile muliedile@gmail.com +251913288238 Debre Tabor
City Postal code Country Position/Affiliation
Debre Tabor Ethiopia Debre Tabor University
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