Background Neonatal mortality is
a significant contributor to under-five deaths. Of the 6.9 million children
under 5 who die annually, more than 43% die in the first month of life.
Breathing problems at the time of birth (i.e., perinatal asphyxia) account for
a major portion of these deaths globally, and approximately 6 million newborns
annually would avoid death or severe neurologic disability if provided
effective breathing assistance (ventilation) within one minute of birth.
Effective resuscitation assistance at the time of birth is lifesaving: every 30
seconds delay in establishing effective ventilation from birth increases the
risk of death by 16% up to 6 minutes for newborns who have not initiated
spontaneous breathing at birth. This finding emphasizes the need to establish
timely Bag-Valve-Mask ventilation. However, one in five trained healthcare
professionals (HCPs) fail to perform the technique correctly, and those that
do, often experience a rapid decline in proficiency. Goal The immediate goal of this study is to better
understand the potential effectiveness of the AIR device in improving the
retention of newborn ventilation skills among SBAs in Kenya and India. The
ultimate goal of improving newborn ventilation skills retention will be to
improve newborn resuscitative care and newborn outcomes. Specific aims 1. To evaluate the impact of the Augmented Infant
Resuscitator (AIR) device feedback on ventilations skills retention over 6
months – at baseline and at approximately 2, 4, and 6 months post-training
– among skilled birth attendants (SBAs) in Kenya and India 2. To understand SBA and supervisor user
experiences in the use of AIR device technology for low-dose
high-frequency (LDHF) ventilation practice 3. To understand costs related to AIR
device implementation and the projected costs for scaling and sustaining
an AIR device program. 4. To collect site-specific, de-identified,
perinatal and early neonatal mortality data as published and recorded by
the Global Network for Maternal and Child Health Research in Kenya and
India. Methods HBB training The study will begin by training and equipping all
available SBAs at the participating facilities in the Helping Babies Breathe
(HBB) training curriculum. It is anticipated that these will be one-day HBB
trainings. SBAs will also receive HBB Provider Guides and wall-mountable HBB
action plans. Immediately before and after training, the study
teams will use the traditional HBB assessment tools (copies of these
instruments are available in the shared AIR Partner Folder): Immediately
pre-training: HBB Knowledge Assessment HBB
Bag-Mask Ventilation Skills Test HBB
OSCE A HBB
OSCE B (with 2-minute ventilation epoch) Immediately
post-training: HBB Knowledge Assessment HBB
Bag-Mask Ventilation Skills Test HBB
OSCE A HBB
OSCE B (with 2-minute ventilation epoch) AIR device training Training in the use of the AIR device is quite
brief and will be integrated into the HBB trainings. By the end of each HBB
training, we expect all providers to be familiar to AIR device use. Study design Eligibility We wish to enroll all skilled birth attendants
(SBAs) (approximately 12 SBAs/facility) from approximately 9-12 health
facilities in Kenya and another 9-12 health facilities in India. Our goal is
approximately 250 total SBAs across the two countries. Inclusion criteria for study participants 1. SBAs working clinically at the selected
facilities (i.e., in-service providers) 2. SBAs who participate in the HBB
training offered by our group at the beginning of the study 3. SBAs who demonstrate competence, after
initial training, in key neonatal resuscitation skills and competencies
(i.e., pass the BMV skills check and OSCE B) 4. SBAs able to adequately understand the
language in which the HBB training is offered (e.g., we anticipate the
trainings will be offered in English) 5. SBAs over 18 years of age 6. SBAs who provide written informed
consent for participation in the study Exclusion criteria for participants 1. Students or clinicians still in training
(i.e., pre-service providers) 2. SBAs and other health workers who do not
participate in initial HBB training 3. SBAs that are unable to adequately
understand the language in which the HBB training is offered 4. SBAs under 18 years of age 5. SBAs who do not provide written informed
consent for participation in the study For all participant SBAs, demographic characteristics,
such as the SBA cadre (doctor, nurse, or midwife), gender, age range, prior
neonatal resuscitation training, etc., will be collected to better
contextualize the study population and permit comparative descriptions. Randomization: Assigning geographic clusters and
study cohorts In each country, to facilitate step-wedge
implementation, selected facilities should be organized into clusters
geographically (e.g., a referral hospital and all if it’s referring
facilities). Study teams will then use a random number generator to assign each
geographic cluster to one of three different intervention time points, Cohorts
A, B, and C Masking Participants in Cohort A will practice with AIR
devices providing visual feedback immediately post-training, while Cohorts B and
C will start with AIR devices without visual feedback. Disabling feedback from
the device does not compromise its recording function that collects
time-stamped data on ventilation quality. Cohort B will switch to AIR device
feedback at 2 months, and Cohort C will switch to AIR device feedback at 4
months. All cohorts will continue LDHF practice with AIR device feedback
through up to 6 months after initial HBB training. AIR device training Once assigned to receive AIR feedback, health
workers will also receive AIR device training. This AIR device training will
focus on device functionality, feedback interpretation and use. In addition,
regular device charging plans will be solidified with each. Meanwhile, control
participants will receive training on how to effectively attach the AIR device
to the resuscitation bag during ventilation practice and to “log in†during
these sessions. Periodic BMV skills assessments During the study, the study teams will conduct
facility-based bag-mask ventilation (BMV) assessments at 2, 4, and 6 months.
The primary outcome for this measurement will be duration and percentage of
time in effective ventilation in a two-minute window after initiation of
ventilation, as part of the HBB program’s existing BMV skills check or OSCE B.
[TO BE DISCUSSED WITH PARTNERS: whether to have the 2-minute ventilation
sessions as part of the BMV skills check, OSCE B., or a completely separate
exercise.] “Effective ventilation†is defined by the cumulative time
ventilating in the correct rate range without airway blockages, significant
leaks, and harsh breaths and will be determined by the AIR device. Note, during
these skills assessments, study participants will be evaluated with feedback
turned off during the two-minute breathing epoch. Post-training
data collection will include: 2 months
post-training: HBB
Bag-Mask Ventilation Skills Test
HBB OSCE B (with 2-minute ventilation epoch) 4 months
post-training: HBB
Bag-Mask Ventilation Skills Test
HBB OSCE B (with 2-minute ventilation epoch) 6 months
post-training: HBB
Bag-Mask Ventilation Skills Test
HBB OSCE B (with 2-minute ventilation epoch)
Focus group discussions / Key-informant interviews
Cost analysis Study outcomes Primary Outcomes 1. Effective bag-mask ventilation 2. Time to effective bag-mask ventilation 3. Bag-mask ventilation skills Secondary Outcomes 1. Provider-level perceptions 2. Cost analysis 3. Perinatal outcomes |