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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03703622
Other study ID # REC REF 2015-085
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 4, 2018
Est. completion date December 31, 2018

Study information

Verified date October 2018
Source Makerere University
Contact Beatrice Odongkara, MBChB, MMed, Fellowship
Phone +256772896397
Email beachristo2003@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Helping babies breathe (HBB) is a neonatal resuscitation training program for low-resource settings to health care workers to provide prompt respiratory support to save babies at birth. Despite massive roll-out, new-born mortality reduction has stagnated over the years. Innovative teaching methods with existing technology such as video-debriefing needs to be tested to promote competence (skills and knowledge) attainment and retention.


Description:

In this study we will randomize both public and private delivery facilities in Lira district northern Uganda to receive either standard HBB with video-debriefing (intervention) or standard training alone (control). We hope video-debriefing will improve competence among the health workers and promote skills and knowledge retention over time, hence reduction in neonatal mortality.

The result of the study may also contribute to shaping refresher training program policy in low-resource settings.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- All health care workers attending to delivery and new-born care in both public and private facilities in Lira district.

Exclusion Criteria:

- Those who turn up for training just for daily allowances, having been sent by their facility in-charges to fill gaps such as community vaccinators, Village Health Teams (VHTs), security officers, cleaners, and laboratory technicians

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video-debriefing with standard HBB training compared with standard HBB training only
We will use the AAP training curriculum for the HBB 2nd edition through out the training and course assessments pre-and post- training and during follow-up period. Both intervention arms will a 2 days training consisting of: lectures, neonatal resuscitation demonstrations using NeoNatali mannequin, and practical skills s sessions. Pre- and post-tests knowledge (MCQs) and skills (bag mask ventilation, OSCE A, & OSCE B) will be given to all participants. In the intervention arm, in addition to standard training, participants will work in teams of three (birth attendant, mother, and an assistant) to perform different HBB case scenarios. These will be filmed and used for subsequent debriefing after each case scenarios. After all participants in the intervention have had the opportunity to participate in the debriefing, then a post test is done to assess performance. Analysis is done to compare the intervention and control arms performances.

Locations

Country Name City State
Uganda All public and Private delivery facilities (hospitals, health centers, maternity homes, and clinics) in Lira district Lira Northern

Sponsors (2)

Lead Sponsor Collaborator
Makerere University University of Bergen

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health workers knowledge scores in percentage The scores from HBB multiple choice questions (MCQs) will be used. 6 months
Primary Health workers skills scores in percentages The scores from bag mask ventilation, OSCE A and B skills sessions will be used. 6 months
Secondary Knowledge and skills retention at 1, 3 and 6 months The knowledge and skills scores as described above will be used to assess retention at different time points 6 months
Secondary Neonatal mortality at health facilities pre- and post training We will determine the mortality at all the birth facilities from maternity registers to determine the effect of our training on birth outcomes 6 months
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