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.: PACTR201708002469225 Date of Approval: 25/07/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Actions to Help Babies Breathe at Birth: Training Interventions to Improve Health Workers Knowledge, Practices and Competency Helping Babies Breathe
Official scientific title Actions to Help Babies Breathe at Birth: Training Interventions to Improve Health Workers Knowledge, Practices and Competency Helping Babies Breathe
Brief summary describing the background and objectives of the trial The aim of the study is to examine the effect of Helping Babies Breathe training interventions program on knowledge, psychomotor skills and competency of the health workers on management of birth asphyxia and reduction of mortality of newborn due to asphyxia in 24 hours The study was pre and post-test (quasi experimental study). Purposive sampling was employed and computer generated number was used to select the participants. The health worker in the intervention and comparison group was evaluated before and after training in period of February ¿ June 2017. A post training skill and competency evaluation was performed on NeoNatalie newborn stimulator. These were repeated after 3 months of implementation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Birth Asphyixia,Neonatal Diseases,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 28/02/2017
Actual trial start date 28/02/2017
Anticipated date of last follow up 01/06/2017
Actual Last follow-up date 01/06/2017
Anticipated target sample size (number of participants) 154
Actual target sample size (number of participants) 70
Recruitment status Completed
Publication URL None
Secondary Ids Issuing authority/Trial register
None Ministry of health Republic of South Sudan
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 randomisation using a radomisation table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training intervention Training 2 day training Training of health workers on standard Heping Babies Protocol. before the training intervention , pre and post training assesment condcuted on the knwledge , skill and comptency and paticipants were allowed to practiced for 3 months and intervention end up evalaution was conducted 40
Control Group Non Intervention- Observation only None None Baseline line, observation , pre and post test and 3 month follow up using the Helping Babies Breathe Protocol 30 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Medical officers/doctors, nurses, midwives, maternal Child Health Officer, community health workers and clinical officers working and practicing in maternity, operating theater and children ward. 2.Health providers self-reported that they actually provide routine care services at delivery and neonatal unit or departments 3.Health workers willing to be available for data collection and during the period of study 1.Health workers who received training on helping Babies Breathe within the last six months prior to the study abroad 25 Year(s) 50 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 21/02/2017 South Sudan Health Research Institute, Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Minstry of Health Headquater, Ministerial building Juba- South Sudan +211 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in Knowledge , pschomotor skill and comptetecy Baseline , pre and post training intervention , 3 months and 6 months
Secondary Outcome Reduction in the ratio of newborn mortality within 24 hours Overall reduction assessed before intervention and three and 6 months intervention and follow up. Data on resuscitation and outcome either died or alive within 24 hours is collected daily form the resuscitation table , neonatal unit and all this analyses at the end of study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Wau Teaching Hospital , Maternity ward , newborn unit and operating theater Wau Wau +211 Sudan
Juba teaching Hospital Maternity ward , newborn unit and operating theater Juba Juba +211 Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Sponsored Mukono Kampala +256 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Christopher Mukono Kampala +256 Uganda Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Dr. Khemia Yamarat Pythai Soi Bangok +662 Thailand
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Christopher Vunni chrissvunni@gmail.com +256786224828 Mukono
City Postal code Country Position/Affiliation
Kampala +256 Uganda PhD studnet Chulalonkron University
Role Name Email Phone Street address
Public Enquiries Riachrd Laku richardlaku@yahoo.com +211(0) 177800 278 Juba - South Sudan
City Postal code Country Position/Affiliation
Juba - South Sudan +211 Sudan Chair of the committe and Director General Policy ,planning budge and Research
Role Name Email Phone Street address
Scientific Enquiries Christopher Vunni chrissvunni@gmail.com +211(0) 177800 278 Kampala
City Postal code Country Position/Affiliation
Kampala +256 Uganda Researcher/ PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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