NCT03703622

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

September 28, 2018

Last Update Submit

October 9, 2018

Conditions

Keywords

HBB knowledge and skills attainment and retentionVideo-debriefingSkills, knowledge, Birth attendants

Outcome Measures

Primary Outcomes (2)

  • Health workers knowledge scores in percentage

    The scores from HBB multiple choice questions (MCQs) will be used.

    6 months

  • Health workers skills scores in percentages

    The scores from bag mask ventilation, OSCE A and B skills sessions will be used.

    6 months

Secondary Outcomes (2)

  • Knowledge and skills retention at 1, 3 and 6 months

    6 months

  • Neonatal mortality at health facilities pre- and post training

    6 months

Study Arms (2)

Video-debriefing with standard HBB training

EXPERIMENTAL

Health workers are given standard HBB training according to American Association of Pediatrics (AAP) plus video-debriefing. Filming of the simulated case scenarios will be done and after which the films will be used for debriefing or feedback. Participants will be encouraged to give feedback with the guidance of master trainer and the PI. Teams of three participants(birth attendant, mother and helper) will perform the HBB simulation or scenarios. After each scenario, debriefing is done until all participants have had the opportunity to participate in the simulation exercise. All the participants in this arm will undergo HBB practical sessions such as bag mask ventilation skills sessions, care of the health new-born and sick newborn baby who needs resuscitation care. Pre and post-tests will be done to assess performance of all participants.

Behavioral: Video-debriefing with standard HBB training compared with standard HBB training only

Standard HBB training only

ACTIVE COMPARATOR

Health workers are given standard HBB training according to AAP without video-debriefing. All the participants in this arm, like in intervention arm, will also undergo HBB practical sessions such as bag mask ventilation skills sessions, care of the health new-born and sick new-born baby who needs resuscitation care only. Pre-and post-tests will be done to assess performance of all participants.

Behavioral: Video-debriefing with standard HBB training compared with standard HBB training only

Interventions

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.

Standard HBB training onlyVideo-debriefing with standard HBB training

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All public and Private delivery facilities (hospitals, health centers, maternity homes, and clinics) in Lira district

Lira, Northern Region, 256, Uganda

RECRUITING

Related Publications (1)

  • Odongkara B, Tylleskar T, Pejovic N, Achora V, Mukunya D, Ndeezi G, Tumwine JK, Nankabirwa V. Adding video-debriefing to Helping-Babies-Breathe training enhanced retention of neonatal resuscitation knowledge and skills among health workers in Uganda: a cluster randomized trial. Glob Health Action. 2020 Dec 31;13(1):1743496. doi: 10.1080/16549716.2020.1743496.

Central Study Contacts

Beatrice Odongkara, MBChB, MMed, Fellowship

CONTACT

Patricia Achola, BLIS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Cluster randomization was done by an independent statistician from the University of Bergen who is not part of the study. The health workers from randomised facilities were randomly assigned to two groups of 24 participants, each to be trained for two days. The participants and the assessors did not know the intervention groups which they belonged to until the day of training. During follow-up the assessors and the PI will not know which intervention arms the participants are in.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The AAP HBB curriculum will be used to train participants. Lectures will be delivered by the PI (Master Trainers), followed by demonstration of HBB skills using NeoNatali Mannequin. The participants will then be divided into two groups. One group for practical sessions with master trainers and the other group video-debriefing. The video-debriefing group will have their practical sessions filmed and then the film used for debriefing feedback. First the experiences of the team performing resuscitation will be obtained then positive feedback and learning points from other learners will be given in a respectful safe environment. All participants will be encouraged to contribute in the discussion. Pre- and Post-Test knowledge and skills will be assessed will be done using MCQs, and bag mask ventilation, OSCE A and B checklists from 2nd edition AAP HBB training manual.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 12, 2018

Study Start

June 4, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will share

After dissemination and Doctor of Philosophy (PhD) defence, I can avail the scores and demographics of the study participants after de-identification of the dataset.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
12 months
Access Criteria
Direct contact to the PI

Locations