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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04258722
Other study ID # IRB-300004483
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2020
Est. completion date January 30, 2023

Study information

Verified date December 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Resuscitation Personnel
Type of resuscitation team

Locations

Country Name City State
United States Children's of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Temperature regulation Infant placed in polyethylene wrap with warming mattress and hat placed on head. From baseline to 30 seconds
Secondary 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
Secondary Heart rate check compliance HR was checked within 60 seconds after birth. From baseline to 60 seconds up to 5 minutes
Secondary 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
Secondary Bag mask ventilation compliance Mask was applied to the infant's face at 60 seconds after birth. From baseline to 60 seconds
Secondary 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
Secondary Sat probe placement compliance Sat probe placed at 60 seconds after birth. From baseline to 60 seconds
Secondary 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
Secondary MR SOPA Performance: Mask adjustment Mask was adjusted on the infant's face From start of bag mask ventilation to 2 minutes
Secondary MR SOPA Performance: Reposition airway infant's neck was adjusted From start of bag mask ventilation to 2 minutes
Secondary MR SOPA Performance: Suction mouth infant's mouth was suctioned From start of bag mask ventilation to 2 minutes
Secondary MR SOPA Performance: Open mouth infant's mouth was opened From start of bag mask ventilation to 2 minutes
Secondary MR SOPA Performance: Increased pressure pressure on bag mask was increased From start of bag mask ventilation to 2 minutes
Secondary MR SOPA Performance: Placed advanced airway endotracheal tube was placed From start of bag mask ventilation to 2 minutes
Secondary MR SOPA performed in correct sequence corrective measures were performed in this sequence From start of bag mask ventilation to 2 minutes
Secondary MR SOPA measures all performed each corrective measure was performed From start of bag mask ventilation to 2 minutes
Secondary Number of steps correctly performed The number of steps correctly performed during the resuscitation From start of bag mask ventilation to 2 minutes
Secondary 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
Secondary 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
Secondary 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
Secondary Compression depth compliance Compressions given at 1/3 of the infant's chest depth From baseline until first compression up to 5 minutes
Secondary 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
Secondary Compression rate per minute Number of compressions within 10 seconds multiplied by 6 From start time of compression until 10 seconds have elapsed
Secondary 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
Secondary 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
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