The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0+
SponsorMayo Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Teleneonatology
Other interventionReal-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.
Treatment groups
947 Participants
are divided into 2 treatment groupsGroup A: Teleneonatology groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
7 daysSecondary outcomes
1
Early neonatal morbidity within the first 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
Time frame
7 days2
Composite outcome of early mortality and morbidity
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.
Time frame
7 days3
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.
Time frame
First hour of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mayo Clinic
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov