Augmented Infant Resuscitator (AIR): Transitioning a novel behavior change innovation to drive newborn ventilation skills enhancement

Background

Neonatal mortality isa significant contributor to under-five deaths. Of the 6.9 million childrenunder 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 fora major portion of these deaths globally, and approximately 6 million newbornsannually would avoid death or severe neurologic disability if providedeffective breathing assistance (ventilation) within one minute of birth.Effective resuscitation assistance at the time of birth is lifesaving: every 30seconds delay in establishing effective ventilation from birth increases therisk of death by 16% up to 6 minutes for newborns who have not initiatedspontaneous breathing at birth. This finding emphasizes the need to establishtimely Bag-Valve-Mask ventilation. However, one in five trained healthcareprofessionals (HCPs) fail to perform the technique correctly, and those thatdo, often experience a rapid decline in proficiency.

Goal

The immediate goal of this study is to betterunderstand the potential effectiveness of the AIR device in improving theretention of newborn ventilation skills among SBAs in Kenya and India. Theultimate goal of improving newborn ventilation skills retention will be toimprove 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 allavailable SBAs at the participating facilities in the Helping Babies Breathe(HBB) training curriculum. It is anticipated that these will be one-day HBBtrainings. SBAs will also receive HBB Provider Guides and wall-mountable HBBaction plans.

Immediately before and after training, the studyteams will use the traditional HBB assessment tools (copies of theseinstruments are available in the shared AIR Partner Folder):

Immediatelypre-training:      HBB Knowledge Assessment

HBBBag-Mask Ventilation Skills Test

HBBOSCE A

HBBOSCE B (with 2-minute ventilation epoch)

Immediatelypost-training:    HBB Knowledge Assessment

HBBBag-Mask Ventilation Skills Test

HBBOSCE A

HBBOSCE B (with 2-minute ventilation epoch)

AIR device training

Training in the use of the AIR device is quitebrief and will be integrated into the HBB trainings. By the end of each HBBtraining, 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 healthfacilities in Kenya and another 9-12 health facilities in India. Our goal isapproximately 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, priorneonatal resuscitation training, etc., will be collected to bettercontextualize the study population and permit comparative descriptions.

Randomization: Assigning geographic clusters andstudy cohorts

In each country, to facilitate step-wedgeimplementation, selected facilities should be organized into clustersgeographically (e.g., a referral hospital and all if it’s referringfacilities). Study teams will then use a random number generator to assign eachgeographic cluster to one of three different intervention time points, CohortsA, B, and C

Masking

Participants in Cohort A will practice with AIRdevices providing visual feedback immediately post-training, while Cohorts B andC will start with AIR devices without visual feedback. Disabling feedback fromthe device does not compromise its recording function that collectstime-stamped data on ventilation quality. Cohort B will switch to AIR devicefeedback at 2 months, and Cohort C will switch to AIR device feedback at 4months. All cohorts will continue LDHF practice with AIR device feedbackthrough up to 6 months after initial HBB training.

AIR device training

Once assigned to receive AIR feedback, healthworkers will also receive AIR device training. This AIR device training willfocus on device functionality, feedback interpretation and use. In addition,regular device charging plans will be solidified with each. Meanwhile, controlparticipants will receive training on how to effectively attach the AIR deviceto the resuscitation bag during ventilation practice and to “log in†duringthese sessions.

Periodic BMV skills assessments

During the study, the study teams will conductfacility-based bag-mask ventilation (BMV) assessments at 2, 4, and 6 months.The primary outcome for this measurement will be duration and percentage oftime in effective ventilation in a two-minute window after initiation ofventilation, 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 ventilationsessions as part of the BMV skills check, OSCE B., or a completely separateexercise.] “Effective ventilation†is defined by the cumulative timeventilating in the correct rate range without airway blockages, significantleaks, and harsh breaths and will be determined by the AIR device. Note, duringthese skills assessments, study participants will be evaluated with feedbackturned off during the two-minute breathing epoch.

Post-trainingdata collection will include:

2 monthspost-training:         HBBBag-Mask Ventilation Skills Test

HBB OSCE B (with 2-minute ventilation epoch)

4 monthspost-training:         HBBBag-Mask Ventilation Skills Test

HBB OSCE B (with 2-minute ventilation epoch)

6 monthspost-training:         HBBBag-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