Provider Perspectives on the Acceptability, Appropriateness, and Feasibility of Teleneonatology.
Jennifer L Fang, Rachel Umoren, Hilary Whyte...
https://pubmed.ncbi.nlm.nih.gov/34583392Actively Recruiting
Phase Not Applicable
Age: 0Days +
All Genders
ID06087224
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Led by Mayo Clinic · Updated on 2025-11-21
947
Participants Needed
36
Research Sites
11 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of real-time audio-video telemedicine consultations with a neonatologist, called teleneonatology, on early health outcomes of at-risk newborns delivered in community hospitals. This study uses a stepped wedge cluster randomized design to compare early mortality, morbidity, and delivery room care between neonates receiving teleneonatology support and those receiving usual care. The trial is led by Mayo Clinic and focuses on newborns facing significant resuscitation needs shortly after birth. The study involves two groups: one where at-risk neonates receive care from the community hospital team with telemedicine support from a neonatologist located at a regional neonatal intensive care unit, and a control group where neonates receive the hospital's usual care without telemedicine consultation. The telemedicine connection allows real-time, two-way audio and video communication during advanced neonatal resuscitations. The study includes neonates born preterm under 32 weeks or requiring advanced resuscitation interventions such as prolonged positive pressure ventilation, alternative airway placement, or chest compressions. Participants include clinicians attending newborn resuscitations and eligible neonates born at participating community hospitals. Researchers will monitor outcomes including mortality within 7 days, early neonatal morbidity, combined mortality and morbidity, and the highest level of resuscitation given in the delivery room within the first hour. The study tracks these outcomes to assess the effect of teleneonatology on newborn health during this critical early period. The total study duration extends through May 2029.
CONDITIONS
Brief Title
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Who Can Participate
Age: 0Days +
All Genders
Eligibility Criteria
You may qualify if you...
- Clinician attending newborn resuscitations at a participating community hospital spoke site who provides informed oral consent
- Neonate born in a participating community hospital spoke site who meets at least one of the following: preterm birth less than 32 weeks' gestation; or need for advanced resuscitation defined by positive pressure ventilation for at least 10 minutes, alternative airway placement, or chest compressions
You will not qualify if you...
- Neonate born outside the hospital birthing center
- Neonatal transport team present at birth providing resuscitative care
- Severe congenital anomaly requiring intensive care or surgery in first two weeks
- Plan for comfort care (non-resuscitation) after delivery
- In-person neonatology-trained physician present during resuscitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - First hour of life
Participants receive telemedicine consultation by a neonatologist during advanced neonatal resuscitations in the delivery room at community hospitals, or receive usual care without telemedicine consultation.
1 delivery room event
Follow-up
Duration - 7 days
Participants are monitored for early mortality and morbidity outcomes within the first 7 days after birth.
Daily monitoring for up to 7 days
Trial Site Locations
Total: 36 locations
1
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Actively Recruiting
2
Bartlett Regional Hospital
Juneau, Alaska, United States, 99801
Actively Recruiting
3
PeaceHealth Ketchikan Medical Center
Ketchikan, Alaska, United States, 99901
Actively Recruiting
4
Mayo Clinic Arizona
Pheonix, Arizona, United States, 85054
Active, Not Recruiting
5
Mayo Clinic Minnesota
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
6
Chickasaw Nation Medical Center
Ada, Oklahoma, United States, 74820
Actively Recruiting
7
Jackson County Memorial Hospital
Altus, Oklahoma, United States, 73521
Actively Recruiting
8
Great Plains Regional Medical Center
Elk City, Oklahoma, United States, 73648
Actively Recruiting
9
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
10
Island Health
Anacortes, Washington, United States, 98221
Actively Recruiting
11
Providence Regional Medical Center Everett
Everett, Washington, United States, 98201
Actively Recruiting
12
Olympic Medical Center
Port Angeles, Washington, United States, 98362
Actively Recruiting
13
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
14
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
15
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, United States, 98801
Actively Recruiting
16
Prairie Ridge Health
Columbus, Wisconsin, United States, 53925
Actively Recruiting
17
Fort HealthCare
Fort Atkinson, Wisconsin, United States, 53538
Actively Recruiting
18
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53715
Actively Recruiting
19
Sauk Prairie Healthcare
Prairie du Sac, Wisconsin, United States, 53578
Actively Recruiting
20
Reedsburg Area Medical Center
Reedsburg, Wisconsin, United States, 53959
Actively Recruiting
21
Watertown Regional Medical Center
Watertown, Wisconsin, United States, 53098
Actively Recruiting
22
Stevenson Memorial Hospital
Alliston, Ontario, Canada, L9R 1W7
Actively Recruiting
23
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, Canada, L6R 3J7
Actively Recruiting
24
Michael Garron Hospital
East York, Ontario, Canada, M4C 3E7
Actively Recruiting
25
William Osler Health System - Etobicoke General Hospital
Etobicoke, Ontario, Canada, M9V 1R8
Actively Recruiting
26
Trillium Health Partners - Credit Valley Health
Mississauga, Ontario, Canada, L5M 2N1
Actively Recruiting
27
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Actively Recruiting
28
Orillia Soldiers Memorial Hospital
Orillia, Ontario, Canada, L3V 2Z3
Actively Recruiting
29
Scarborough Health Network - Centenary Hospital
Scarborough Village, Ontario, Canada, M1E 4B9
Actively Recruiting
30
Scarborough Health Network - General Hospital
Scarborough Village, Ontario, Canada, M1P 2V5
Actively Recruiting
31
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Actively Recruiting
32
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
33
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
34
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
35
Unity Health - St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Actively Recruiting
36
Mackenzie Health - Cortellucci Vaughan Hospital
Vaughan, Ontario, Canada, L6A 4Z3
Actively Recruiting
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Research Team
J
Jennifer Fang, MD, MS
B
Bart M Demaerschalk, MD, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Accuracy of Simulated Research Tasks by Community Hospitals Participating in a Multicenter Telemedicine Trial.
Jennifer L Fang, Hilary Whyte, Rachel Umoren...
https://pubmed.ncbi.nlm.nih.gov/35167373Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial.
Jennifer L Fang, Rachel A Umoren, Hilary Whyte...
https://pubmed.ncbi.nlm.nih.gov/37208433