The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
NCT ID: NCT06087224
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
947 participants
INTERVENTIONAL
2024-03-05
2029-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study
NCT04258722
Preemie Hypothermia for Neonatal Encephalopathy
NCT01793129
Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth
NCT01545271
Late Hypothermia for Hypoxic-Ischemic Encephalopathy
NCT00614744
An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.
NCT06898801
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
Control group
Study eligible neonates cared for by the community hospital team per the site's usual practice of care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
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 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.
0 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Mayo Clinic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer L. Fang
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Fang, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Bart M Demaerschalk, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Meegan G Van Straaten, MSPH
Role: STUDY_DIRECTOR
Mayo Clinic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Providence Alaska Medical Center
Anchorage, Alaska, United States
Bartlett Regional Hospital
Juneau, Alaska, United States
PeaceHealth Ketchikan Medical Center
Ketchikan, Alaska, United States
Mayo Clinic Arizona
Pheonix, Arizona, United States
Mayo Clinic Minnesota
Rochester, Minnesota, United States
Chickasaw Nation Medical Center
Ada, Oklahoma, United States
Jackson County Memorial Hospital
Altus, Oklahoma, United States
Great Plains Regional Medical Center
Elk City, Oklahoma, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Island Health
Anacortes, Washington, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
Olympic Medical Center
Port Angeles, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, United States
Prairie Ridge Health
Columbus, Wisconsin, United States
Fort HealthCare
Fort Atkinson, Wisconsin, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Sauk Prairie Healthcare
Prairie du Sac, Wisconsin, United States
Reedsburg Area Medical Center
Reedsburg, Wisconsin, United States
Watertown Regional Medical Center
Watertown, Wisconsin, United States
Stevenson Memorial Hospital
Alliston, Ontario, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, Canada
Michael Garron Hospital
East York, Ontario, Canada
William Osler Health System - Etobicoke General Hospital
Etobicoke, Ontario, Canada
Trillium Health Partners - Credit Valley Health
Mississauga, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
Orillia Soldiers Memorial Hospital
Orillia, Ontario, Canada
Scarborough Health Network - Centenary Hospital
Scarborough Village, Ontario, Canada
Scarborough Health Network - General Hospital
Scarborough Village, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Unity Health - St. Joseph's Health Centre
Toronto, Ontario, Canada
Mackenzie Health - Cortellucci Vaughan Hospital
Vaughan, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Fang 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.
Fang 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.
Related Links
Access external resources that provide additional context or updates about the study.
Mayo Clinic Clinical Trials
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-005502
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.