Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

Study Overview
=================
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.

Official Title
-----------------
Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

Conditions
-----------------
Newborn Morbidity

Intervention / Treatment
-----------------
* Other: Resuscitation Personnel


Participation Criteria
=================
Eligibility Criteria
-----------------
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. Exclusion Criteria: Does not meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trainee + Teleneonatologist<br>Trainee, teleneonatologist, nurse, and respiratory therapist will perform resuscitation | Other: Resuscitation Personnel<br>* Type of resuscitation team<br>|
| Active Comparator: Trainee<br>Trainee, nurse, and respiratory therapist will perform resuscitation. | Other: Resuscitation Personnel<br>* Type of resuscitation team<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No flow fraction | 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) | From start time of compression until 60 seconds have elapsed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperature regulation | Infant placed in polyethylene wrap with warming mattress and hat placed on head. | From baseline to 30 seconds | 
| Time of first heart rate check (seconds) | 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. | From baseline until heart rate check up to 5 minutes | 
| Heart rate check compliance | HR was checked within 60 seconds after birth. | From baseline to 60 seconds up to 5 minutes | 
| Time of bag mask ventilation (seconds) | The number of seconds elapsed at the time the mask was first applied to the infant's face. | From baseline to bag mask placement up to 5 minutes | 
| Bag mask ventilation compliance | Mask was applied to the infant's face at 60 seconds after birth. | From baseline to 60 seconds | 
| Time of sat probe placement (seconds) | The number of seconds elapsed at the time the oxygen saturation probe was placed. | From baseline to probe placement up to 5 minutes | 
| Sat probe placement compliance | Sat probe placed at 60 seconds after birth. | From baseline to 60 seconds | 
| Time of increase in FiO2 (seconds) | The number of seconds elapsed at the time the amount of oxygen administered was increased. | From simulation start to time of FiO2 increase up to 5 minutes | 
| MR SOPA Performance: Mask adjustment | Mask was adjusted on the infant's face | From start of bag mask ventilation to 2 minutes | 
| MR SOPA Performance: Reposition airway | infant's neck was adjusted | From start of bag mask ventilation to 2 minutes | 
| MR SOPA Performance: Suction mouth | infant's mouth was suctioned | From start of bag mask ventilation to 2 minutes | 
| MR SOPA Performance: Open mouth | infant's mouth was opened | From start of bag mask ventilation to 2 minutes | 
| MR SOPA Performance: Increased pressure | pressure on bag mask was increased | From start of bag mask ventilation to 2 minutes | 
| MR SOPA Performance: Placed advanced airway | endotracheal tube was placed | From start of bag mask ventilation to 2 minutes | 
| MR SOPA performed in correct sequence | corrective measures were performed in this sequence | From start of bag mask ventilation to 2 minutes | 
| MR SOPA measures all performed | each corrective measure was performed | From start of bag mask ventilation to 2 minutes | 
| Number of steps correctly performed | The number of steps correctly performed during the resuscitation | From start of bag mask ventilation to 2 minutes | 
| Time to effective ventilation (seconds) | The number of seconds elapsed at the time the mannequin had visible chest rise | From time of bag mask placement until chest rise up to 5 minutes | 
| Time to first compression (seconds) | The number of seconds elapsed at the time the first chest compression was performed | From baseline until first compression up to 5 minutes | 
| Correct hand position | Hands positioned with either two fingers on the mannequin's sternum or thumbs over the sternum with hands encircling the chest | From baseline until first compression up to 5 minutes | 
| Compression depth compliance | Compressions given at 1/3 of the infant's chest depth | From baseline until first compression up to 5 minutes | 
| Compression synchronization compliance | Synchronization with bag mask ventilation with a rate of 3 compressions: 1 ventilation | From start time of compression until 60 seconds have elapsed | 
| Compression rate per minute | Number of compressions within 10 seconds multiplied by 6 | From start time of compression until 10 seconds have elapsed | 
| No blow fraction | 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) | From baseline to 10 minutes | 
| Time to effective ventilation (seconds) | The number of seconds elapsed at the time the mannequin is intubated and ventilated | From baseline to time of first ventilated breath with an endotracheal tube up to 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telemedicine, simulation, neonatal resuscitation