The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 947
- Locations
- 64
- Primary Endpoint
- 7-day mortality rate
Study Overview
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 delivered in community hospitals.
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 "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 0 Days to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Teleneonatology group
Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU).
Intervention: Teleneonatology (Other)
Control group
Study eligible neonates cared for by the community hospital team per the site's usual practice of care.
Outcomes
Primary Outcomes
7-day mortality rate
Time Frame: 7 days
Percentage of neonates classified as dying within 7 days, defined as death on or before 23:59 on the seventh completed day of life.
Secondary Outcomes
- Early neonatal morbidity within the first 7 days(7 days)
- Highest level of resuscitation received in the delivery room(First hour of life)
- Composite outcome of early mortality and morbidity(7 days)
Investigators
Jennifer L. Fang
Principal Investigator
Mayo Clinic