Clinical trial NCT05349175: Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
Official title: Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asphyxia Neonatorum
Birth Asphyxia
Perinatal Asphyxia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
name: Grand Challenges Canada
First posted: 2022-04-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Augmented Infant Resuscitator (AIR) is an inexpensive add-on, compatible with nearly every existing bag-valve mask and many types of ventilation equipment. AIR monitors ventilation quality and provides real-time objective feedback and actionable cues to clinicians to both shorten training times and improve resuscitation quality, adoption, retention, and confidence.

Detailed description: The investigators propose a randomized controlled trial to asses the impact, feasibility, and acceptability of real-time visual feedback from the AIR device. The study will begin by training and equipping all available skilled birth attendants (SBAs) at the participating facilities in the Helping Babies Breathe (HBB) training curriculum. 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 to evaluate SBAs' HBB knowledge and skills.

Facilities will then be randomized, by cluster, to either receive AIR feedback at the start of the trial (Cohort A) or beginning at 2 (Cohort B) or 4 months post-training (Cohort C). Both intervention and control cohorts will be encouraged to start regular "low-dose, high-frequency" (LDHF) practice with the AIR devices. LDHF involves frequent "doses" of shorter, often skills- or competency-based, individual- or pair-learning practice sessions. Study teams will establish HBB practice corners in each health facility, consisting of HBB equipment, NeoNatalie, AIR device, HBB Action Plan, and a log book.

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.

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 of effective ventilation in a two-minute window after initiation of ventilation, as part of the HBB program's existing BMV skills check and OSCE B. "Effective ventilation" is defined as 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.

After AIR feedback is turned on at a facility, de-identified device-recorded data on provider-level frequency and quality of practice will be aggregated, shared, and discussed with each health center every 2 months to support and harmonize with their existing facility-led quality improvement efforts.

Eligibility criteria: Inclusion Criteria:

* Skilled birth attendants (SBAs) working clinically at the selected facilities (i.e., in-service providers)
* SBAs who participate in the HBB training offered by our group at the beginning of the study
* SBAs who demonstrate competence, after initial training, in key neonatal resuscitation skills and competencies (i.e., pass the BMV skills check and OSCE B)
* SBAs able to adequately understand the language in which the HBB training is offered (e.g., the investigators anticipate the trainings will be offered in English)
* SBAs over 18 years of age
* SBAs who provide written informed consent for participation in the study

Exclusion Criteria:

* Students or clinicians still in training (i.e., pre-service providers)
* SBAs and other health workers who do not participate in initial HBB training
* SBAs that are unable to adequately understand the language in which the HBB training is offered
* SBAs under 18 years of age
* SBAs who do not provide written informed consent for participation in the study

Primary outcomes:
measure: Effective bag-mask ventilation
timeFrame: 2 minutes
measure: Time to effective bag-mask ventilation
timeFrame: 2 minutes
measure: Bag-mask ventilation skills immediately after training
timeFrame: Immediately after training
measure: Bag-mask ventilation skills 2 months post-training
timeFrame: 2 months after training
measure: Bag-mask ventilation skills 4 months post-training
timeFrame: 4 months after training
measure: Bag-mask ventilation skills 6 months post-training
timeFrame: 6 months after training
Secondary outcomes:
measure: Provider-level perceptions - focus groups
timeFrame: 6 months
measure: Provider-level perceptions - interviews
timeFrame: 6 months
measure: Cost analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Brett D. Nelson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bennett DJ, Itagaki T, Chenelle CT, Bittner EA, Kacmarek RM. Evaluation of the Augmented Infant Resuscitator: A Monitoring Device for Neonatal Bag-Valve-Mask Resuscitation. Anesth Analg. 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.
citation: Ali A, Nudel J, Heberle CR, Santorino D, Olson KR, Hur C. Cost effectiveness of a novel device for improving resuscitation of apneic newborns. BMC Pediatr. 2020 Jan 30;20(1):46. doi: 10.1186/s12887-020-1925-5.