The TELENEO Trial: a Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
- Conditions
- Death; NeonatalMorbidity;Newborn
- Interventions
- Other: Teleneonatology
- Registration Number
- NCT06087224
- Lead Sponsor
- Mayo Clinic
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 947
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.
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
-
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Teleneonatology group Teleneonatology Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU).
- Primary Outcome Measures
Name Time Method 7-day mortality rate 7 days Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life.
- Secondary Outcome Measures
Name Time Method Early neonatal morbidity within the first 7 days 7 days Percentage of neonates classified as having early neonatal morbidity, defined as diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging (grade 3 or 4 intraventricular hemorrhage per Papile classification or cerebellar hemorrhage), or seizures on electroencephalogram in the first seven days of life
Highest level of resuscitation received in the delivery room First hour of life The highest level of delivery room resuscitation during the first hour of life, on a scale of 1-6, corresponding to routine care; oxygen and/or continuous positive airway pressure (CPAP); positive pressure ventilation (PPV); advanced airway placement (endotracheal tube or laryngeal mask); chest compressions; or epinephrine administration, respectively.
Composite outcome of early mortality and morbidity 7 days Percentage of neonates classified as having early neonatal mortality or morbidity, defined as dying or diagnosed with definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging, or seizures on electroencephalogram in the first seven days of life.
Trial Locations
- Locations (34)
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, Ontario, Canada
Scarborough Health Network - General Hospital
🇨🇦Scarborough, 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
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
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