Recruiting

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

Sponsor:

Mayo Clinic

Code:

NCT06087224

Conditions

Death; Neonatal

Morbidity;Newborn

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Teleneonatology

Study Details

Brief 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.

Conditions

Death; Neonatal

Morbidity;Newborn

Study ID

NCT06087224

Start date

Mar 5, 2024

Status verified date

Nov, 2025

Completion date

May 1, 2029

Anticipated

Primary completion date

Feb 7, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

947 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Teleneonatology group

Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU).

no intervention: Control group

Study eligible neonates cared for by the community hospital team per the site's usual practice of care.

Interventions

Teleneonatology

Real-time, two way, audio-video telemedicine connection between the neonatologist located in the regional neonatal intensive care unit (NICU) and the physician located at the community hospital.

Primary outcome measure

7-day mortality rate [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Jennifer Fang, MD, MS

5072669397 fang.jennifer@mayo.edu

Bart M Demaerschalk, MD, MSc

4803018000 demaerschalk.bart@mayo.edu

Locations

Providence Alaska Medical Center

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Teresa Lam, MD

907-562-2211 teresa.lam@pediatrix.com

Mary-Alice Johnson, MD

Mary.Johnson@providence.org

Bartlett Regional Hospital

Recruiting

Juneau, Alaska, United States, 99801

Contacts

Jessica Sperry, RN

907-796-8657 jmsperry@bartletthospital.org

PeaceHealth Ketchikan Medical Center

Recruiting

Ketchikan, Alaska, United States, 99901

Contacts

Kristin Fahey, RN

907-225-5171 KFahey@peacehealth.org

Chickasaw Nation Medical Center

Recruiting

Ada, Oklahoma, United States, 74820

Contacts

Jonathan Walther, MD

(580) 436-3980 Jonathan.Walther@Chickasaw.net

Bobby Saunkeah

bobby.saunkeah@chickasaw.net

Jackson County Memorial Hospital

Recruiting

Altus, Oklahoma, United States, 73521

Contacts

Lindsey King, MD

580-379-5000 LindseyKing@jcmh.com

Great Plains Regional Medical Center

Recruiting

Elk City, Oklahoma, United States, 73648

Contacts

Courtney Allen, BSN

580-821-5326 callen@gprmc-ok.com

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Erin Bohon

405-271-5215 Erin-Bohon@ouhsc.edu

Principal Investigator:

Samuel Levin, MD

Island Health

Recruiting

Anacortes, Washington, United States, 98221

Contacts

Jason Hogge, MD

360-299-1300 jhogge@islandhospital.org

Providence Regional Medical Center Everett

Recruiting

Everett, Washington, United States, 98201

Contacts

Mihai Puia-Dumitrescu, MD, MPH

207-838-9606 mihaipd@uw.edu

Olympic Medical Center

Recruiting

Port Angeles, Washington, United States, 98362

Contacts

Laura Bullen, MD

360-477-9447 lbullen@olympicmedical.org

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

John Feltner

206-987-2599 jfeltner@uw.edu

Principal Investigator:

Mark Lo, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

John Feltner

206-543-3200 jfeltner@uw.edu

Principal Investigator:

Rachel Umoren, MD

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

Recruiting

Wenatchee, Washington, United States, 98801

Contacts

Brenda Baumeister, MD

509-662-1511 brenda.baumeister@confluencehealth.org

Prairie Ridge Health

Recruiting

Columbus, Wisconsin, United States, 53925

Contacts

Rachel Svendsen, RN

920-623-1299 rsvendsen@prairieridge.health

Fort HealthCare

Recruiting

Fort Atkinson, Wisconsin, United States, 53538

Contacts

Deborah Schumacher, RN

920-568-5000 deborah.schumacher@forthc.com

University of Wisconsin-Madison

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Cassie Nelson

608-417-6236 cenelson4@wisc.edu

Principal Investigator:

Jamie Limjoco, MD

Sauk Prairie Healthcare

Recruiting

Prairie du Sac, Wisconsin, United States, 53578

Contacts

Todd Schad, MD

608-643-3311 tschad@prairieclinic.com

Reedsburg Area Medical Center

Recruiting

Reedsburg, Wisconsin, United States, 53959

Contacts

Anne Harris, MD

608-888-2696 aharris@ramchealth.org

Watertown Regional Medical Center

Recruiting

Watertown, Wisconsin, United States, 53098

Contacts

Patricia Gedemer, RN

920-261-4210 pgedeme@watertownregional.com

Stevenson Memorial Hospital

Recruiting

Alliston, Ontario, Canada, L9R 1W7

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Ihab Khalil, MBBS

William Osler Health System - Brampton Civic Hospital

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Sangeet Kathuria, MBBS

Michael Garron Hospital

Recruiting

East York, Ontario, Canada, M4C 3E7

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Sehr Ansari, MBBS

William Osler Health System - Etobicoke General Hospital

Recruiting

Etobicoke, Ontario, Canada, M9V 1R8

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Sangeet Kathuria, MBBS

Trillium Health Partners - Credit Valley Health

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Maura Mansur

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Madeline Drake, MB, BCh

Orillia Soldiers Memorial Hospital

Recruiting

Orillia, Ontario, Canada, L3V 2Z3

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Ryan Smith, MD

Scarborough Health Network - Centenary Hospital

Recruiting

Scarborough Village, Ontario, Canada, M1E 4B9

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Peter Azzopardi, MD

Scarborough Health Network - General Hospital

Recruiting

Scarborough Village, Ontario, Canada, M1P 2V5

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Peter Azzopardi, MD

North York General Hospital

Recruiting

Toronto, Ontario, Canada, M2K 1E1

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Shaheen Doctor, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Eugene Ng, MD

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Prakesh Shah, MBBS

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Brenda Graydon

brenda.graydon@sickkids.ca

Principal Investigator:

Marko Culjat, MD, M.Sc., PhD

Unity Health - St. Joseph's Health Centre

Recruiting

Toronto, Ontario, Canada, M6R 1B5

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Rana Esmaeilizand, MD

Mackenzie Health - Cortellucci Vaughan Hospital

Recruiting

Vaughan, Ontario, Canada, L6A 4Z3

Contacts

Ashley Mehta

1-416-813-7654 ashley.mehta@sickkids.ca

Principal Investigator:

Hannah Oatley, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Nov 21, 2025

Last verified

Nov, 2025

Keywords

Telemedicine
Newborn
Resuscitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-11-21.