Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

Not Applicable

Completed

• Conditions: Newborn Morbidity
• Interventions: Other: Resuscitation Personnel

• Registration Number: NCT04258722
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care, may bridge the resuscitation quality gap by connecting centers with lower level care to experienced care providers. Using randomized trial design, this investigation will compare teleneonatal resuscitation facilitated by a neonatologist to standard resuscitation within a simulated environment.

Detailed Description

Multiple studies have evaluated telemedicine using simulation, but the level of evidence for the use of telemedicine to improve neonatal resuscitation is low.

In this investigation and within a simulated environment, pediatric interns and residents will resuscitate a simulated 25 week infant at delivery assisted by a simulated nurse and respiratory therapist. Participants will be randomized to resuscitation performed either with or without telemedicine facilitated by a neonatologist. The primary outcome will be time to effective ventilation with other secondary outcomes including metrics derived from the American Academy of Pediatrics Neonatal Resuscitation Program.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-04
• Study First Posted: 2020-02-06
• Study Start: 2020-11-30
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Inclusion criteria for experienced providers include at least 3 years of pediatric and/or neonatal training, having previously performed >10 endotracheal intubations, and may include neonatologists, pediatric fellows, and neonatal nurse practitioners. Inclusion criteria for trainees: previous exposure to NRP, an interval of > 3 months elapsing between previous NRP applications, and may include pediatric residents, family medicine residents, nurses, respiratory therapists, neonatal fellows, and neonatal attendings.

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Exclusion Criteria

• Does not meet inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trainee + Teleneonatologist	Resuscitation Personnel	Trainee, teleneonatologist, nurse, and respiratory therapist will perform resuscitation
Trainee	Resuscitation Personnel	Trainee, nurse, and respiratory therapist will perform resuscitation.

Primary Outcome Measures

Name	Time	Method
No flow fraction	From start time of compression until 60 seconds have elapsed	The proportion of time for which the mannequin received no effective compression (the number of seconds without effective chest compressions divided by the total number of seconds)

Secondary Outcome Measures

Name	Time	Method
Compression rate per minute	From start time of compression until 10 seconds have elapsed	Number of compressions within 10 seconds multiplied by 6
Time of first heart rate check (seconds)	From baseline until heart rate check up to 5 minutes	The number of seconds elapsed at the time the heart rate was first checked either by stethoscope, palpation of umbilical stump, or by EKG lead.
Temperature regulation	From baseline to 30 seconds	Infant placed in polyethylene wrap with warming mattress and hat placed on head.
Sat probe placement compliance	From baseline to 60 seconds	Sat probe placed at 60 seconds after birth.
MR SOPA Performance: Increased pressure	From start of bag mask ventilation to 2 minutes	pressure on bag mask was increased
Heart rate check compliance	From baseline to 60 seconds up to 5 minutes	HR was checked within 60 seconds after birth.
Time of sat probe placement (seconds)	From baseline to probe placement up to 5 minutes	The number of seconds elapsed at the time the oxygen saturation probe was placed.
Time of bag mask ventilation (seconds)	From baseline to bag mask placement up to 5 minutes	The number of seconds elapsed at the time the mask was first applied to the infant's face.
Bag mask ventilation compliance	From baseline to 60 seconds	Mask was applied to the infant's face at 60 seconds after birth.
MR SOPA Performance: Suction mouth	From start of bag mask ventilation to 2 minutes	infant's mouth was suctioned
MR SOPA Performance: Placed advanced airway	From start of bag mask ventilation to 2 minutes	endotracheal tube was placed
Number of steps correctly performed	From start of bag mask ventilation to 2 minutes	The number of steps correctly performed during the resuscitation
No blow fraction	From baseline to 10 minutes	The proportion of time for which the mannequin received no effective ventilation (the number of seconds without effective ventilation divided by the total number of seconds)
Time of increase in FiO2 (seconds)	From simulation start to time of FiO2 increase up to 5 minutes	The number of seconds elapsed at the time the amount of oxygen administered was increased.
MR SOPA Performance: Mask adjustment	From start of bag mask ventilation to 2 minutes	Mask was adjusted on the infant's face
MR SOPA Performance: Reposition airway	From start of bag mask ventilation to 2 minutes	infant's neck was adjusted
MR SOPA Performance: Open mouth	From start of bag mask ventilation to 2 minutes	infant's mouth was opened
Time to effective ventilation (seconds)	From baseline to time of first ventilated breath with an endotracheal tube up to 10 minutes	The number of seconds elapsed at the time the mannequin is intubated and ventilated
Time to first compression (seconds)	From baseline until first compression up to 5 minutes	The number of seconds elapsed at the time the first chest compression was performed
Correct hand position	From baseline until first compression up to 5 minutes	Hands positioned with either two fingers on the mannequin's sternum or thumbs over the sternum with hands encircling the chest
Compression depth compliance	From baseline until first compression up to 5 minutes	Compressions given at 1/3 of the infant's chest depth
MR SOPA performed in correct sequence	From start of bag mask ventilation to 2 minutes	corrective measures were performed in this sequence
MR SOPA measures all performed	From start of bag mask ventilation to 2 minutes	each corrective measure was performed
Compression synchronization compliance	From start time of compression until 60 seconds have elapsed	Synchronization with bag mask ventilation with a rate of 3 compressions: 1 ventilation

Trial Locations

Locations (1)

Children's of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States