What side effects are associated with this type of intervention?

Common treatments for neonatal asphyxia, such as bag-valve-mask ventilation and CPAP, can have several side effects. These may include lung injury due to overinflation (barotrauma), air leaks (pneumothorax), and potential damage to the delicate tissues of the lungs. Additionally, improper ventilation can lead to inadequate oxygenation or carbon dioxide removal, which can cause further complications. The use of real-time feedback and monitoring, as seen with the Augmented Infant Resuscitator (AIR), aims to mitigate these risks by improving the quality and consistency of ventilation.

What prior FDA approvals exist?

The FDA has approved various treatments and devices for Neonatal Asphyxia, focusing on improving ventilation quality. One notable example is the Augmented Infant Resuscitator (AIR), which provides real-time feedback and monitoring to enhance the quality of resuscitation efforts. This device is compatible with existing bag-valve masks and other ventilation equipment, aiming to improve training, adoption, and retention of effective resuscitation techniques. While specific drugs for Neonatal Asphyxia are not highlighted, the emphasis remains on advanced resuscitation devices that ensure better outcomes through enhanced monitoring and feedback.

What other types of research exist?

Promising novel alternatives to the Augmented Infant Resuscitator (AIR) for neonatal asphyxia patients include: 1) Advanced neonatal resuscitation simulators that provide real-time feedback and training for healthcare providers, 2) Smart bag-valve-mask devices with integrated sensors for monitoring ventilation parameters, and 3) Automated neonatal resuscitation systems that adjust ventilation settings based on continuous monitoring of the infant's physiological responses. These innovations aim to enhance the quality of neonatal resuscitation by providing actionable feedback and improving the precision of ventilation support.

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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

Must not have

SBAs under 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a device called AIR that helps healthcare workers improve baby resuscitation by giving real-time feedback. It aims to enhance the skills and confidence of birth attendants by monitoring ventilation quality and providing visual cues. The AIR device is low-cost, reusable, and offers objective feedback during resuscitations.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Activation Analysis

Provider-level perceptions - focus groups

Provider-level perceptions - interviews

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neonatal asphyxia treatment primarily involves resuscitation techniques to restore adequate oxygenation and ventilation. The Augmented Infant Resuscitator (AIR) enhances traditional bag-valve-mask ventilation by providing real-time feedback on ventilation quality, helping clinicians adjust their technique for optimal oxygen delivery. This is crucial for neonatal asphyxia patients as effective ventilation directly impacts their immediate survival and long-term neurological outcomes.

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