The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
2 other identifiers
interventional
947
2 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2023
CompletedFirst Posted
Study publicly available on registry
October 17, 2023
CompletedStudy Start
First participant enrolled
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2029
November 21, 2025
November 1, 2025
4.9 years
October 12, 2023
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-day mortality rate
Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life.
7 days
Secondary Outcomes (3)
Early neonatal morbidity within the first 7 days
7 days
Composite outcome of early mortality and morbidity
7 days
Highest level of resuscitation received in the delivery room
First hour of life
Study Arms (2)
Teleneonatology group
EXPERIMENTALStudy eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU).
Control group
NO INTERVENTIONStudy eligible neonates cared for by the community hospital team per the site's usual practice of care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- GROUP 1: Community hospital clinicians
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- A clinician who attends newborn resuscitations at a participating community hospital spoke site.
- Provision of informed oral consent prior to any mandatory study specific procedures and analyses.
- Preterm birth at less than 32 weeks' gestation at delivery; OR
- Need for advanced resuscitation defined as:
- positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR
- placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR
- chest compressions.
You may not qualify if:
- 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:
- Birth outside of the hospital birthing center.
- Neonatal transport team present at time of birth and providing resuscitative care.
- Severe congenital anomaly necessitating intensive care or surgery in the first two weeks of life.
- Plan for comfort care (non-resuscitation) following delivery.
- In-person neonatology-trained physician present for the resuscitation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
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
Related Publications (3)
Fang JL, Umoren R, Whyte H, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Colby CE, Herrin J, Jacobson RM, Demaerschalk BM. Provider Perspectives on the Acceptability, Appropriateness, and Feasibility of Teleneonatology. Am J Perinatol. 2023 Oct;40(14):1521-1528. doi: 10.1055/a-1656-6363. Epub 2021 Sep 28.
PMID: 34583392BACKGROUNDFang JL, Whyte H, Umoren R, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Herrin J, Demaerschalk BM. Accuracy of Simulated Research Tasks by Community Hospitals Participating in a Multicenter Telemedicine Trial. Telemed J E Health. 2022 Oct;28(10):1489-1495. doi: 10.1089/tmj.2021.0574. Epub 2022 Feb 15.
PMID: 35167373BACKGROUNDFang JL, Umoren RA, Whyte H, Limjoco J, Makkar A, Behl S, Lo MD, White L, Culjat M, Taylor JS, Kathuria S, Webb MO, Schad T, Shafranski S, Yankanah R, Herrin J, Demaerschalk BM. Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial. Pediatr Res. 2023 Oct;94(4):1555-1561. doi: 10.1038/s41390-023-02659-2. Epub 2023 May 19.
PMID: 37208433BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Fang, MD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Bart M Demaerschalk, MD
Mayo Clinic
- STUDY DIRECTOR
Meegan G Van Straaten, MSPH
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 12, 2023
First Posted
October 17, 2023
Study Start
March 5, 2024
Primary Completion (Estimated)
February 7, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share