Status:
RECRUITING
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Death; Neonatal
Morbidity;Newborn
Eligibility:
All Genders
Phase:
NA
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 delive...
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 "teleneo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
947 Patients enrolled
Trial Details
Trial ID
NCT06087224
Start Date
March 5 2024
End Date
May 1 2029
Last Update
November 21 2025
Active Locations (36)
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1
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
2
Bartlett Regional Hospital
Juneau, Alaska, United States, 99801
3
PeaceHealth Ketchikan Medical Center
Ketchikan, Alaska, United States, 99901
4
Mayo Clinic Arizona
Pheonix, Arizona, United States, 85054