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
Qualifiers
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
Treatments tested in this trial
- Teleneonatology
Treatment groups
947 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov