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Completed

NCT Number: NCT04258722

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.

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Key information

Conditions

Newborn Morbidity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resuscitation Personnel

Other

Type of resuscitation team

Primary outcomes

  1. No flow fraction

    Time frame: From start time of compression until 60 seconds have elapsed

    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)

Secondary outcomes

  1. Temperature regulation

    Time frame: From baseline to 30 seconds

    Infant placed in polyethylene wrap with warming mattress and hat placed on head.

  2. Time of first heart rate check (seconds)

    Time frame: From baseline until heart rate check up to 5 minutes

    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.

  3. Heart rate check compliance

    Time frame: From baseline to 60 seconds up to 5 minutes

    HR was checked within 60 seconds after birth.

  4. Time of bag mask ventilation (seconds)

    Time frame: From baseline to bag mask placement up to 5 minutes

    The number of seconds elapsed at the time the mask was first applied to the infant's face.

  5. Bag mask ventilation compliance

    Time frame: From baseline to 60 seconds

    Mask was applied to the infant's face at 60 seconds after birth.

  6. Time of sat probe placement (seconds)

    Time frame: From baseline to probe placement up to 5 minutes

    The number of seconds elapsed at the time the oxygen saturation probe was placed.

  7. Sat probe placement compliance

    Time frame: From baseline to 60 seconds

    Sat probe placed at 60 seconds after birth.

  8. Time of increase in FiO2 (seconds)

    Time frame: From simulation start to time of FiO2 increase up to 5 minutes

    The number of seconds elapsed at the time the amount of oxygen administered was increased.

  9. MR SOPA Performance: Mask adjustment

    Time frame: From start of bag mask ventilation to 2 minutes

    Mask was adjusted on the infant's face

  10. MR SOPA Performance: Reposition airway

    Time frame: From start of bag mask ventilation to 2 minutes

    infant's neck was adjusted

  11. MR SOPA Performance: Suction mouth

    Time frame: From start of bag mask ventilation to 2 minutes

    infant's mouth was suctioned

  12. MR SOPA Performance: Open mouth

    Time frame: From start of bag mask ventilation to 2 minutes

    infant's mouth was opened

  13. MR SOPA Performance: Increased pressure

    Time frame: From start of bag mask ventilation to 2 minutes

    pressure on bag mask was increased

  14. MR SOPA Performance: Placed advanced airway

    Time frame: From start of bag mask ventilation to 2 minutes

    endotracheal tube was placed

  15. MR SOPA performed in correct sequence

    Time frame: From start of bag mask ventilation to 2 minutes

    corrective measures were performed in this sequence

  16. MR SOPA measures all performed

    Time frame: From start of bag mask ventilation to 2 minutes

    each corrective measure was performed

  17. Number of steps correctly performed

    Time frame: From start of bag mask ventilation to 2 minutes

    The number of steps correctly performed during the resuscitation

  18. Time to effective ventilation (seconds)

    Time frame: From time of bag mask placement until chest rise up to 5 minutes

    The number of seconds elapsed at the time the mannequin had visible chest rise

  19. Time to first compression (seconds)

    Time frame: From baseline until first compression up to 5 minutes

    The number of seconds elapsed at the time the first chest compression was performed

  20. Correct hand position

    Time frame: From baseline until first compression up to 5 minutes

    Hands positioned with either two fingers on the mannequin's sternum or thumbs over the sternum with hands encircling the chest

  21. Compression depth compliance

    Time frame: From baseline until first compression up to 5 minutes

    Compressions given at 1/3 of the infant's chest depth

  22. Compression synchronization compliance

    Time frame: From start time of compression until 60 seconds have elapsed

    Synchronization with bag mask ventilation with a rate of 3 compressions: 1 ventilation

  23. Compression rate per minute

    Time frame: From start time of compression until 10 seconds have elapsed

    Number of compressions within 10 seconds multiplied by 6

  24. No blow fraction

    Time frame: From baseline to 10 minutes

    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)

  25. Time to effective ventilation (seconds)

    Time frame: From baseline to time of first ventilated breath with an endotracheal tube up to 10 minutes

    The number of seconds elapsed at the time the mannequin is intubated and ventilated

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2020
Registry last updated
Dec 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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