Telemedicine for neonatal resuscitation in community hospitals
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
NA · Mayo Clinic · NCT06087224
This study tests if using video calls with neonatologists can help improve the care and health outcomes for newborns in community hospitals who need immediate medical attention.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 947 (estimated) |
| Ages | 0 Days and up |
| Sex | All |
| Sponsor | Mayo Clinic (other) |
| Locations | 36 sites (Anchorage, Alaska and 35 other locations) |
| Trial ID | NCT06087224 on ClinicalTrials.gov |
What this trial studies
This multicenter trial evaluates the effectiveness of real-time audio-video telemedicine consults with neonatologists, known as teleneonatology, on improving health outcomes for at-risk neonates delivered in community hospitals. The study employs a stepped wedge cluster randomized design to assess the impact on early mortality and morbidity rates, as well as the quality of delivery room care. By integrating telemedicine into neonatal resuscitation practices, the trial aims to enhance the support available to clinicians in community settings.
Who should consider this trial
Good fit: Ideal candidates include at-risk neonates born in participating community hospitals, particularly those who are preterm or require advanced resuscitation.
Not a fit: Patients who are not born in participating community hospitals or do not meet the criteria for at-risk neonates may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce early mortality and morbidity rates in at-risk neonates.
How similar studies have performed: Other studies have shown promising results with telemedicine in neonatal care, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Anchorage, Alaska and 35 other locations
- Providence Alaska Medical Center — Anchorage, Alaska, United States (RECRUITING)
- Bartlett Regional Hospital — Juneau, Alaska, United States (RECRUITING)
- PeaceHealth Ketchikan Medical Center — Ketchikan, Alaska, United States (RECRUITING)
- Mayo Clinic Arizona — Pheonix, Arizona, United States (ACTIVE_NOT_RECRUITING)
- Mayo Clinic Minnesota — Rochester, Minnesota, United States (ACTIVE_NOT_RECRUITING)
- Chickasaw Nation Medical Center — Ada, Oklahoma, United States (RECRUITING)
- Jackson County Memorial Hospital — Altus, Oklahoma, United States (RECRUITING)
- Great Plains Regional Medical Center — Elk City, Oklahoma, United States (RECRUITING)
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (RECRUITING)
- Island Health — Anacortes, Washington, United States (RECRUITING)
- Providence Regional Medical Center Everett — Everett, Washington, United States (RECRUITING)
- Olympic Medical Center — Port Angeles, Washington, United States (RECRUITING)
- Seattle Children's Hospital — Seattle, Washington, United States (RECRUITING)
- University of Washington — Seattle, Washington, United States (RECRUITING)
- Central Washington Health Services Association d/b/a Confluence Health — Wenatchee, Washington, United States (RECRUITING)
- Prairie Ridge Health — Columbus, Wisconsin, United States (RECRUITING)
- Fort HealthCare — Fort Atkinson, Wisconsin, United States (RECRUITING)
- University of Wisconsin-Madison — Madison, Wisconsin, United States (RECRUITING)
- Sauk Prairie Healthcare — Prairie du Sac, Wisconsin, United States (RECRUITING)
- Reedsburg Area Medical Center — Reedsburg, Wisconsin, United States (RECRUITING)
- Watertown Regional Medical Center — Watertown, Wisconsin, United States (RECRUITING)
- Stevenson Memorial Hospital — Alliston, Ontario, Canada (RECRUITING)
- William Osler Health System - Brampton Civic Hospital — Brampton, Ontario, Canada (RECRUITING)
- Michael Garron Hospital — East York, Ontario, Canada (RECRUITING)
- William Osler Health System - Etobicoke General Hospital — Etobicoke, Ontario, Canada (RECRUITING)
- Trillium Health Partners - Credit Valley Health — Mississauga, Ontario, Canada (RECRUITING)
- Southlake Regional Health Centre — Newmarket, Ontario, Canada (RECRUITING)
- Orillia Soldiers Memorial Hospital — Orillia, Ontario, Canada (RECRUITING)
- Scarborough Health Network - Centenary Hospital — Scarborough Village, Ontario, Canada (RECRUITING)
- Scarborough Health Network - General Hospital — Scarborough Village, Ontario, Canada (RECRUITING)
- North York General Hospital — Toronto, Ontario, Canada (RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
- Mount Sinai Hospital — Toronto, Ontario, Canada (RECRUITING)
- The Hospital for Sick Children — Toronto, Ontario, Canada (RECRUITING)
- Unity Health - St. Joseph's Health Centre — Toronto, Ontario, Canada (RECRUITING)
- Mackenzie Health - Cortellucci Vaughan Hospital — Vaughan, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Jennifer Fang, MD — Mayo Clinic
- Study coordinator: Jennifer Fang, MD, MS
- Email: fang.jennifer@mayo.edu
- Phone: 5072669397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Death, Neonatal, Morbidity, Newborn, Telemedicine, Resuscitation