Asphyxia NeonatorumNCT05349175
Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
A study testing Augmented Infant Resuscitator (AIR) in people with Asphyxia Neonatorum and Birth Asphyxia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
- What is being tested?
- Augmented Infant Resuscitator (AIR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
- Being tested
- Augmented Infant Resuscitator (AIR)
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Infant Resuscitator (AIR)Device
Real-time visual feedback from the AIR device regarding quality of bag-mask ventilation
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Receives AIR device feedback beginning immediately after training Receives: Device: Augmented Infant Resuscitator (AIR) |
| Cohort B | Experimental | Receives AIR device feedback beginning 2 months after training Receives: Device: Augmented Infant Resuscitator (AIR) |
| Cohort C | Experimental | Receives AIR device feedback beginning 4 months after training Receives: Device: Augmented Infant Resuscitator (AIR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective bag-mask ventilation
Duration of effective bag-mask ventilation by clinician during a 2-minute trial. This is measured internally from the AIR device. "Effective ventilation" is defined as having all three of the following conditions simultaneously: (1) Correct rate (30-60 breaths per minute); (2) Absence of significant leak (compliance >4.0mL/cm H2O); and (3) Absence of a significant airway blockage (defined as compliance <0.10 mL/cm H2O or resistance >90 cmH2O/L/s). These measurements are determined by sensors in the AIR device for all arms of the study. Their accuracy for manikin use was determined to be 100% in the following trial: Bennett el al. Anesth Analgesia. 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.
Measured: 2 minutes
Time to effective bag-mask ventilation
How long it takes for clinician to achieve effective ventilation during 2-minute trial -- timed from when the mask first touches the face of the manikin until all three icons are green. This is measured by an observer using a stop-watch. Again, "effective ventilation" is defined as having all three of the following conditions simultaneously and is indicated to the RA by all three icons on the AIR device turning green: (1) Correct rate (30-60 breaths per minute); (2) Absence of significant leak (compliance >4.0mL/cm H2O); and (3) Absence of a significant airway blockage (defined as compliance <0.10 mL/cm H2O or resistance >90 cmH2O/L/s).
Measured: 2 minutes
Bag-mask ventilation skills immediately after training
Clinicians' bag-mask ventilation skills will be assessed immediately after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
Measured: Immediately after training
Bag-mask ventilation skills 2 months post-training
Clinicians' bag-mask ventilation skills will be assessed 2 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
Measured: 2 months after training
Bag-mask ventilation skills 4 months post-training
Clinicians' bag-mask ventilation skills will be assessed 4 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
Measured: 4 months after training
Bag-mask ventilation skills 6 months post-training
Clinicians' bag-mask ventilation skills will be assessed 6 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
Measured: 6 months after training
Secondary outcomes (3)
Provider-level perceptions - focus groups
Provider perceptions of the AIR device, using focus group discussions.
Measured: 6 months
Provider-level perceptions - interviews
Provider perceptions of the AIR device, using semi-structured interviews.
Measured: 6 months
Cost analysis
Cost analysis for implementation and evaluation of the AIR device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start1 Feb 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Asphyxia NeonatorumStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Grand Challenges Canada
- Responsible party
- Principal investigator, Brett D. Nelson, MD, MPH, DTM&H, Massachusetts General Hospital
- Investigators
- Brett D. Nelson, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349175
- Sponsor's protocol ID
- 2013P002204b
- Status last verified
- Nov 2025
- First submitted
- 15 Apr 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28863023Ali 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.
PubMed 32000740
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement
- ClinicalTrials.gov ID
- NCT05349175
- Acronym / sponsor ID
- 2013P002204b
- Conditions
- Asphyxia Neonatorum, Birth Asphyxia, Perinatal Asphyxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), Grand Challenges Canada
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Device: Augmented Infant Resuscitator (AIR)Receives AIR device feedback beginning immediately after training |
| Cohort B | Experimental | Device: Augmented Infant Resuscitator (AIR)Receives AIR device feedback beginning 2 months after training |
| Cohort C | Experimental | Device: Augmented Infant Resuscitator (AIR)Receives AIR device feedback beginning 4 months after training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Infant Resuscitator (AIR)Real-time visual feedback from the AIR device regarding quality of bag-mask ventilation | Device | Cohort A, Cohort B, Cohort C |
Primary outcome
Effective bag-mask ventilation
Time frame: 2 minutes
Duration of effective bag-mask ventilation by clinician during a 2-minute trial. This is measured internally from the AIR device. "Effective ventilation" is defined as having all three of the following conditions simultaneously: (1) Correct rate (30-60 breaths per minute); (2) Absence of significant leak (compliance >4.0mL/cm H2O); and (3) Absence of a significant airway blockage (defined as compliance <0.10 mL/cm H2O or resistance >90 cmH2O/L/s). These measurements are determined by sensors in the AIR device for all arms of the study. Their accuracy for manikin use was determined to be 100% in the following trial: Bennett el al. Anesth Analgesia. 2018 Mar;126(3):947-955. doi: 10.1213/ANE.0000000000002432.
Time to effective bag-mask ventilation
Time frame: 2 minutes
How long it takes for clinician to achieve effective ventilation during 2-minute trial -- timed from when the mask first touches the face of the manikin until all three icons are green. This is measured by an observer using a stop-watch. Again, "effective ventilation" is defined as having all three of the following conditions simultaneously and is indicated to the RA by all three icons on the AIR device turning green: (1) Correct rate (30-60 breaths per minute); (2) Absence of significant leak (compliance >4.0mL/cm H2O); and (3) Absence of a significant airway blockage (defined as compliance <0.10 mL/cm H2O or resistance >90 cmH2O/L/s).
Bag-mask ventilation skills immediately after training
Time frame: Immediately after training
Clinicians' bag-mask ventilation skills will be assessed immediately after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
Bag-mask ventilation skills 2 months post-training
Time frame: 2 months after training
Clinicians' bag-mask ventilation skills will be assessed 2 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
Bag-mask ventilation skills 4 months post-training
Time frame: 4 months after training
Clinicians' bag-mask ventilation skills will be assessed 4 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
Bag-mask ventilation skills 6 months post-training
Time frame: 6 months after training
Clinicians' bag-mask ventilation skills will be assessed 6 months after training. Assessment of these skills will be done using current standards, namely the HBB program's 'Bag-mask ventilation skills test' and 'OSCE B.'
3 secondary outcomes
Provider-level perceptions - focus groups
Time frame: 6 months
Provider-level perceptions - interviews
Time frame: 6 months
Cost analysis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Results publication: PubMed 28863023Bennett 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.
- Results publication: PubMed 32000740Ali 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett D. Nelson, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Infant Resuscitator (AIR) in people with Asphyxia Neonatorum and Birth Asphyxia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective bag-mask ventilation (time frame: 2 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05349175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.