The TELENEO Trial: a Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

Last updated: December 5, 2024
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Teleneonatology

Clinical Study ID

NCT06087224
23-005502
R01HD112327
  • All Genders

Study Summary

The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

GROUP 1: Community hospital clinicians

To be eligible to participate in this study, an individual must meet all of the following criteria:

  1. A clinician who attends newborn resuscitations at a participating community hospitalspoke site.

  2. Provision of informed oral consent prior to any mandatory study specific proceduresand analyses.

GROUP 2: At-risk outborn neonates To be eligible for this study, a neonate born in a participating community hospital spoke site must meet at least one of the following inclusion criteria

  1. Preterm birth at less than 32 weeks' gestation at delivery; OR

  2. Need for advanced resuscitation defined as:

  3. positive pressure ventilation (PPV) initiated soon after birth and continuedfor at least 10 minutes; OR

  4. placement of an alternative airway (endotracheal tube or laryngeal mask) toprovide PPV; OR

  5. chest compressions.

Exclusion

Exclusion Criteria:

GROUP 1: Community hospital clinicians None

GROUP 2: At-risk outborn neonates

A neonate born in a participating community hospital spoke site who meets any of the following criteria will be excluded from the study:

  1. Birth outside of the hospital birthing center.

  2. Neonatal transport team present at time of birth and providing resuscitative care.

  3. Severe congenital anomaly necessitating intensive care or surgery in the first twoweeks of life.

  4. Plan for comfort care (non-resuscitation) following delivery.

  5. In-person neonatology-trained physician present for the resuscitation.

Study Design

Total Participants: 947
Treatment Group(s): 1
Primary Treatment: Teleneonatology
Phase:
Study Start date:
March 05, 2024
Estimated Completion Date:
May 01, 2029

Study Description

This prospective, multicenter trial will use a stepped wedge cluster randomized study design to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.

Connect with a study center

  • Stevenson Memorial Hospital

    Alliston, Ontario L9R 1W7
    Canada

    Active - Recruiting

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • Michael Garron Hospital

    East York, Ontario M4C 3E7
    Canada

    Active - Recruiting

  • William Osler Health System - Etobicoke General Hospital

    Etobicoke, Ontario M9V 1R8
    Canada

    Active - Recruiting

  • Trillium Health Partners - Credit Valley Health

    Mississauga, Ontario L5M 2N1
    Canada

    Active - Recruiting

  • Southlake Regional Health Centre

    Newmarket, Ontario L3Y 2P9
    Canada

    Active - Recruiting

  • Orillia Soldiers Memorial Hospital

    Orillia, Ontario L3V 2Z3
    Canada

    Active - Recruiting

  • Scarborough Health Network - Centenary Hospital

    Scarborough, Ontario M1E 4B9
    Canada

    Active - Recruiting

  • Scarborough Health Network - General Hospital

    Scarborough, Ontario M1P 2V5
    Canada

    Active - Recruiting

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Active - Recruiting

  • North York General Hospital

    Toronto, Ontario M2K 1E1
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Active - Recruiting

  • Unity Health - St. Joseph's Health Centre

    Toronto, Ontario M6R 1B5
    Canada

    Active - Recruiting

  • Mackenzie Health - Cortellucci Vaughan Hospital

    Vaughan, Ontario L6A 4Z3
    Canada

    Active - Recruiting

  • Bartlett Regional Hospital

    Juneau, Alaska 99801
    United States

    Active - Recruiting

  • PeaceHealth Ketchikan Medical Center

    Ketchikan, Alaska 99901
    United States

    Active - Recruiting

  • Mayo Clinic Arizona

    Pheonix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic Minnesota

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Jackson County Memorial Hospital

    Altus, Oklahoma 73521
    United States

    Active - Recruiting

  • Great Plains Regional Medical Center

    Elk City, Oklahoma 73648
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • Island Health

    Anacortes, Washington 98221
    United States

    Active - Recruiting

  • Providence Regional Medical Center Everett

    Everett, Washington 98201
    United States

    Active - Recruiting

  • Olympic Medical Center

    Port Angeles, Washington 98362
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

  • University of Washington

    Seattle, Washington 98195
    United States

    Active - Recruiting

  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington 98801
    United States

    Active - Recruiting

  • Prairie Ridge Health

    Columbus, Wisconsin 53925
    United States

    Active - Recruiting

  • Fort HealthCare

    Fort Atkinson, Wisconsin 53538
    United States

    Active - Recruiting

  • University of Wisconsin-Madison

    Madison, Wisconsin 53715
    United States

    Active - Recruiting

  • Sauk Prairie Healthcare

    Prairie du Sac, Wisconsin 53578
    United States

    Active - Recruiting

  • Reedsburg Area Medical Center

    Reedsburg, Wisconsin 53959
    United States

    Active - Recruiting

  • Watertown Regional Medical Center

    Watertown, Wisconsin 53098
    United States

    Active - Recruiting

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