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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
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 moreSecondary 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
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.
Meta-analysis of Oxygenation Saturation Targeting Trials: Do Infant Subgroups Matter?Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol.
Meta-analysis of Oxygenation Saturation Targeting Trials: Do Infant Subgroups Matter?Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
3,000 Previous Clinical Trials
13,308,356 Total Patients Enrolled
1 Trials studying Neonatal Asphyxia
270 Patients Enrolled for Neonatal Asphyxia
United States Agency for International Development (USAID)FED
208 Previous Clinical Trials
1,523,680 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I have participated in the HBB training offered at the start of the study.I understand English well enough for training purposes.I am over 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort C
- Group 3: Cohort A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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