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NCT06087224NARecruiting

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

Mayo Clinic

Start Date

3/5/2024

Completion Date

5/1/2029

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.

Detailed 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.

Eligibility Criteria

Age Range: No minimum to No maximum

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 hospital spoke site. 2. Provision of informed oral consent prior to any mandatory study specific procedures and 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: 1. positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR 2. placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR 3. chest compressions. 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 two weeks of life. 4. Plan for comfort care (non-resuscitation) following delivery. 5. In-person neonatology-trained physician present for the resuscitation.

Interventions

OTHER

Teleneonatology

Interested in This Trial?

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Conditions

Death; NeonatalMorbidity;Newborn

Locations

Providence Alaska Medical Center

Anchorage, Alaska 99508

United States

Bartlett Regional Hospital

Juneau, Alaska 99801

United States

PeaceHealth Ketchikan Medical Center

Ketchikan, Alaska 99901

United States

Mayo Clinic Arizona

Pheonix, Arizona 85054

United States

Mayo Clinic Minnesota

Rochester, Minnesota 55905

United States

Chickasaw Nation Medical Center

Ada, Oklahoma 74820

United States

Jackson County Memorial Hospital

Altus, Oklahoma 73521

United States

Great Plains Regional Medical Center

Elk City, Oklahoma 73648

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Island Health

Anacortes, Washington 98221

United States

Providence Regional Medical Center Everett

Everett, Washington 98201

United States

Olympic Medical Center

Port Angeles, Washington 98362

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

University of Washington

Seattle, Washington 98195

United States

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

Wenatchee, Washington 98801

United States

Prairie Ridge Health

Columbus, Wisconsin 53925

United States

Fort HealthCare

Fort Atkinson, Wisconsin 53538

United States

University of Wisconsin-Madison

Madison, Wisconsin 53715

United States

Sauk Prairie Healthcare

Prairie du Sac, Wisconsin 53578

United States

Reedsburg Area Medical Center

Reedsburg, Wisconsin 53959

United States

Watertown Regional Medical Center

Watertown, Wisconsin 53098

United States

Stevenson Memorial Hospital

Alliston, Ontario L9R 1W7

Canada

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario L6R 3J7

Canada

Michael Garron Hospital

East York, Ontario M4C 3E7

Canada

William Osler Health System - Etobicoke General Hospital

Etobicoke, Ontario M9V 1R8

Canada

Trillium Health Partners - Credit Valley Health

Mississauga, Ontario L5M 2N1

Canada

Southlake Regional Health Centre

Newmarket, Ontario L3Y 2P9

Canada

Orillia Soldiers Memorial Hospital

Orillia, Ontario L3V 2Z3

Canada

Scarborough Health Network - Centenary Hospital

Scarborough Village, Ontario M1E 4B9

Canada

Scarborough Health Network - General Hospital

Scarborough Village, Ontario M1P 2V5

Canada

North York General Hospital

Toronto, Ontario M2K 1E1

Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

Mount Sinai Hospital

Toronto, Ontario M5G 1X5

Canada

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

Unity Health - St. Joseph's Health Centre

Toronto, Ontario M6R 1B5

Canada

Mackenzie Health - Cortellucci Vaughan Hospital

Vaughan, Ontario L6A 4Z3

Canada