RecruitingNot ApplicableNCT06087224
The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Sponsor
Mayo Clinic
Enrollment
947 participants
Start Date
Mar 5, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 0 Days
Inclusion Criteria9
- 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.
- 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 Criteria8
- 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.
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Interventions
OTHERTeleneonatology
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.
Locations(36)
View Full Details on ClinicalTrials.gov
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NCT06087224