The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

Study Overview
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Brief Summary
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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
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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.

Official Title
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The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

Conditions
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Death; Neonatal, Morbidity;Newborn

Intervention / Treatment
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* Other: Teleneonatology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GROUP 1: Community hospital physicians To be eligible to participate in this study, an individual must meet all of the following criteria: A physician 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 Criteria: GROUP 1: Community hospital physicians A physician who meets the following criteria will be excluded from the study: 1. Completion of a neonatal-perinatal medicine fellowship 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped wedge cluster randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teleneonatology group<br>Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU). | Other: Teleneonatology<br>* 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.<br>|
| No Intervention: Control group<br>Study eligible neonates cared for by the community hospital team per the site's usual practice of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day mortality rate | Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early neonatal morbidity within the first 7 days | Percentage of neonates classified as having early neonatal morbidity, defined as diagnosed with pneumothorax on chest radiograph, 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 | 7 days | 
| Composite outcome of early mortality and morbidity | Percentage of neonates classified as having early neonatal mortality or morbidity, defined as dying or diagnosed with pneumothorax on chest radiograph, severe intracranial hemorrhage on brain imaging, or seizures on electroencephalogram in the first seven days of life. | 7 days | 
| Highest level of resuscitation received in the delivery room | 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. | First hour of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Newborn, Resuscitation