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Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04258722
Enrollment
51
Registered
2020-02-06
Start date
2020-11-30
Completion date
2023-01-30
Last updated
2023-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn Morbidity

Keywords

telemedicine, simulation, neonatal resuscitation

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.

Interventions

OTHERResuscitation Personnel

Type of resuscitation team

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessors will be masked to group allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
No flow fractionFrom start time of compression until 60 seconds have elapsedThe 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

MeasureTime frameDescription
Time of first heart rate check (seconds)From baseline until heart rate check up to 5 minutesThe number of seconds elapsed at the time the heart rate was first checked either by stethoscope, palpation of umbilical stump, or by EKG lead.
Heart rate check complianceFrom baseline to 60 seconds up to 5 minutesHR was checked within 60 seconds after birth.
Time of bag mask ventilation (seconds)From baseline to bag mask placement up to 5 minutesThe number of seconds elapsed at the time the mask was first applied to the infant's face.
Bag mask ventilation complianceFrom baseline to 60 secondsMask was applied to the infant's face at 60 seconds after birth.
Time of sat probe placement (seconds)From baseline to probe placement up to 5 minutesThe number of seconds elapsed at the time the oxygen saturation probe was placed.
Sat probe placement complianceFrom baseline to 60 secondsSat probe placed at 60 seconds after birth.
Time of increase in FiO2 (seconds)From simulation start to time of FiO2 increase up to 5 minutesThe number of seconds elapsed at the time the amount of oxygen administered was increased.
MR SOPA Performance: Mask adjustmentFrom start of bag mask ventilation to 2 minutesMask was adjusted on the infant's face
MR SOPA Performance: Reposition airwayFrom start of bag mask ventilation to 2 minutesinfant's neck was adjusted
MR SOPA Performance: Suction mouthFrom start of bag mask ventilation to 2 minutesinfant's mouth was suctioned
MR SOPA Performance: Open mouthFrom start of bag mask ventilation to 2 minutesinfant's mouth was opened
Temperature regulationFrom baseline to 30 secondsInfant placed in polyethylene wrap with warming mattress and hat placed on head.
MR SOPA Performance: Placed advanced airwayFrom start of bag mask ventilation to 2 minutesendotracheal tube was placed
MR SOPA performed in correct sequenceFrom start of bag mask ventilation to 2 minutescorrective measures were performed in this sequence
MR SOPA measures all performedFrom start of bag mask ventilation to 2 minuteseach corrective measure was performed
Number of steps correctly performedFrom start of bag mask ventilation to 2 minutesThe number of steps correctly performed during the resuscitation
Time to effective ventilation (seconds)From time of bag mask placement until chest rise up to 5 minutesThe number of seconds elapsed at the time the mannequin had visible chest rise
Time to first compression (seconds)From baseline until first compression up to 5 minutesThe number of seconds elapsed at the time the first chest compression was performed
Correct hand positionFrom baseline until first compression up to 5 minutesHands positioned with either two fingers on the mannequin's sternum or thumbs over the sternum with hands encircling the chest
Compression depth complianceFrom baseline until first compression up to 5 minutesCompressions given at 1/3 of the infant's chest depth
Compression synchronization complianceFrom start time of compression until 60 seconds have elapsedSynchronization with bag mask ventilation with a rate of 3 compressions: 1 ventilation
Compression rate per minuteFrom start time of compression until 10 seconds have elapsedNumber of compressions within 10 seconds multiplied by 6
No blow fractionFrom baseline to 10 minutesThe 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)
MR SOPA Performance: Increased pressureFrom start of bag mask ventilation to 2 minutespressure on bag mask was increased

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026