Resuscitation Personnel for Newborn Illness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Newborn IllnessResuscitation Personnel - Other
Eligibility
18 - 75
All Sexes
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Study Summary

This trial will compare teleneonatal resuscitation, which uses audio-video communication to connect experienced care providers with centers that have lower levels of care, to standard resuscitation in a simulated environment.

Treatment Effectiveness

Study Objectives

0 Primary · 25 Secondary · Reporting Duration: From baseline to 60 seconds up to 5 minutes

From baseline to 10 minutes
No blow fraction
From baseline to 30 seconds
Temperature regulation
From baseline to 60 seconds
Bag mask ventilation compliance
Sat probe placement compliance
From baseline to 60 seconds up to 5 minutes
Heart rate check compliance
From baseline to bag mask placement up to 5 minutes
Time of bag mask ventilation (seconds)
From baseline to probe placement up to 5 minutes
Time of sat probe placement (seconds)
From baseline until first compression up to 5 minutes
Compression depth compliance
Correct hand position
Time to first compression (seconds)
From baseline until heart rate check up to 5 minutes
Time of first heart rate check (seconds)
From simulation start to time of FiO2 increase up to 5 minutes
Time of increase in FiO2 (seconds)
From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Increased pressure
MR SOPA Performance: Mask adjustment
MR SOPA Performance: Open mouth
MR SOPA Performance: Placed advanced airway
MR SOPA Performance: Reposition airway
MR SOPA Performance: Suction mouth
MR SOPA measures all performed
MR SOPA performed in correct sequence
Number of steps correctly performed
From start time of compression until 10 seconds have elapsed
Compression rate per minute
From start time of compression until 60 seconds have elapsed
Compression synchronization compliance
No flow fraction
From time of bag mask placement until chest rise up to 5 minutes
Time to effective ventilation (seconds)

Trial Safety

Trial Design

2 Treatment Groups

Trainee
1 of 2
Trainee + Teleneonatologist
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Resuscitation Personnel · No Placebo Group · N/A

Trainee + Teleneonatologist
Other
Experimental Group · 1 Intervention: Resuscitation Personnel · Intervention Types: Other
Trainee
Other
ActiveComparator Group · 1 Intervention: Resuscitation Personnel · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to 60 seconds up to 5 minutes

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,435 Previous Clinical Trials
2,229,174 Total Patients Enrolled
Samuel Gentle, MDPrincipal Investigator - University of Alabama at Birmingham
El Camino Hospital
Medical School - University of South Alabama, Doctor of Medicine
University of Alabama, Residency in Internal Medicine

Eligibility Criteria

Age 18 - 75 · All Participants · 1 Total Inclusion Criteria

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