Clinical trial NCT04258722: Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study
Official title: Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Morbidity
Keywords: telemedicine
simulation
neonatal resuscitation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: No flow fraction
timeFrame: From start time of compression until 60 seconds have elapsed
Secondary outcomes:
measure: Temperature regulation
timeFrame: From baseline to 30 seconds
measure: Time of first heart rate check (seconds)
timeFrame: From baseline until heart rate check up to 5 minutes
measure: Heart rate check compliance
timeFrame: From baseline to 60 seconds up to 5 minutes
measure: Time of bag mask ventilation (seconds)
timeFrame: From baseline to bag mask placement up to 5 minutes
measure: Bag mask ventilation compliance
timeFrame: From baseline to 60 seconds
measure: Time of sat probe placement (seconds)
timeFrame: From baseline to probe placement up to 5 minutes
measure: Sat probe placement compliance
timeFrame: From baseline to 60 seconds
measure: Time of increase in FiO2 (seconds)
timeFrame: From simulation start to time of FiO2 increase up to 5 minutes
measure: MR SOPA Performance: Mask adjustment
timeFrame: From start of bag mask ventilation to 2 minutes
measure: MR SOPA Performance: Reposition airway
timeFrame: From start of bag mask ventilation to 2 minutes
measure: MR SOPA Performance: Suction mouth
timeFrame: From start of bag mask ventilation to 2 minutes
measure: MR SOPA Performance: Open mouth
timeFrame: From start of bag mask ventilation to 2 minutes
measure: MR SOPA Performance: Increased pressure
timeFrame: From start of bag mask ventilation to 2 minutes
measure: MR SOPA Performance: Placed advanced airway
timeFrame: From start of bag mask ventilation to 2 minutes
measure: MR SOPA performed in correct sequence
timeFrame: From start of bag mask ventilation to 2 minutes
measure: MR SOPA measures all performed
timeFrame: From start of bag mask ventilation to 2 minutes
measure: Number of steps correctly performed
timeFrame: From start of bag mask ventilation to 2 minutes
measure: Time to effective ventilation (seconds)
timeFrame: From time of bag mask placement until chest rise up to 5 minutes
measure: Time to first compression (seconds)
timeFrame: From baseline until first compression up to 5 minutes
measure: Correct hand position
timeFrame: From baseline until first compression up to 5 minutes
measure: Compression depth compliance
timeFrame: From baseline until first compression up to 5 minutes
measure: Compression synchronization compliance
timeFrame: From start time of compression until 60 seconds have elapsed
measure: Compression rate per minute
timeFrame: From start time of compression until 10 seconds have elapsed
measure: No blow fraction
timeFrame: From baseline to 10 minutes
measure: Time to effective ventilation (seconds)
timeFrame: From baseline to time of first ventilated breath with an endotracheal tube up to 10 minutes
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Samuel Gentle, MD
role: PRINCIPAL_INVESTIGATOR
References: