Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Newborn Morbidity
• Intervention / Treatment: Other: Resuscitation Personnel

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Samuel Gentle, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): January 30, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: simulation; telemedicine; neonatal resuscitation
• Other Study ID Numbers: IRB-300004483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No