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Behavioural Intervention

AIR Device for Neonatal Asphyxia

N/A

Waitlist Available

Led By Brett D. Nelson, MD, MPH

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial found that the use of AIR during infant CPR can improve quality of care and confidence of providers.

Who is the study for?

This trial is for skilled birth attendants over 18 who work at selected facilities, have passed neonatal resuscitation skills checks after initial training, and can understand the language of the Helping Babies Breathe (HBB) training. They must consent to participate. Trainee clinicians or those unable to understand the training language are excluded.Check my eligibility

What is being tested?

The Augmented Infant Resuscitator (AIR) is being tested; it's an add-on for bag-valve masks that gives feedback to improve newborn resuscitation techniques during asphyxia. The goal is to enhance skill adoption, retention, and confidence in a clinical setting.See study design

What are the potential side effects?

Since AIR provides feedback on ventilation quality without direct patient contact, there are no direct side effects from its use. However, improper application of learned skills could potentially affect patient outcomes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Bag-mask ventilation skills 2 months post-training

Bag-mask ventilation skills 4 months post-training

Bag-mask ventilation skills 6 months post-training

+3 more

Secondary outcome measures

Activation Analysis

Provider-level perceptions - focus groups

Provider-level perceptions - interviews

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort CExperimental Treatment1 Intervention

Receives AIR device feedback beginning 4 months after training

Group II: Cohort BExperimental Treatment1 Intervention

Receives AIR device feedback beginning 2 months after training

Group III: Cohort AExperimental Treatment1 Intervention

Receives AIR device feedback beginning immediately after training

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Augmented Infant Resuscitator (AIR)

2016

N/A

~270

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,105 Total Patients Enrolled

1 Trials studying Neonatal Asphyxia

270 Patients Enrolled for Neonatal Asphyxia

United States Agency for International Development (USAID)FED

202 Previous Clinical Trials

1,477,194 Total Patients Enrolled

1 Trials studying Neonatal Asphyxia

3,440 Patients Enrolled for Neonatal Asphyxia

Grand Challenges CanadaOTHER

62 Previous Clinical Trials

95,416 Total Patients Enrolled

2 Trials studying Neonatal Asphyxia

59 Patients Enrolled for Neonatal Asphyxia

Media Library

Augmented Infant Resuscitator (AIR) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05349175 — N/A

Neonatal Asphyxia Research Study Groups: Cohort B, Cohort C, Cohort A

Neonatal Asphyxia Clinical Trial 2023: Augmented Infant Resuscitator (AIR) Highlights & Side Effects. Trial Name: NCT05349175 — N/A

Augmented Infant Resuscitator (AIR) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05349175 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the application window for this research currently open?

"Sadly, this clinical trial is not enrolling any more participants. It was initially posted on September 1st 2022 and last modified in August of the same year. Nonetheless, there are many other medical studies still actively seeking patients."

Answered by AI

Recent research and studies

Anesthesia & AnalgesiaJournal

Evaluation of the Augmented Infant Resuscitator

Bennett, Desmond J., Taiga Itagaki, Christopher T. Chenelle, Edward A. Bittner, and Robert M. Kacmarek. 2018. “Evaluation of the Augmented Infant Resuscitator”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000002432.

BMC PediatricsJournal

Cost Effectiveness of a Novel Device for Improving Resuscitation of Apneic Newborns

Ali, Ayman, Jacob Nudel, Curtis R. Heberle, Data Santorino, Kristian R. Olson, and Chin Hur. 2020. “Cost Effectiveness of a Novel Device for Improving Resuscitation of Apneic Newborns”. BMC Pediatrics. Springer Science and Business Media LLC. doi:10.1186/s12887-020-1925-5.

clinicaltrials.govStudy

Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement

Brett D. Nelson, MD, MPH, DTM&H 2023. "Augmented Infant Resuscitator (AIR): Transitioning a Novel Behavior Change Innovation to Drive Newborn Ventilation Skills Enhancement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05349175.