The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Teleneonatology.
- Who it may be relevant to
- Registry conditions: Death; Neonatal, Morbidity;Newborn. Basic parameters: from 0 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Teleneonatology
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.
Primary outcome measures
- 7-day mortality rate [Time frame: 7 days]
Secondary outcome measures (3)
- Early neonatal morbidity within the first 7 days [Time frame: 7 days]
- Composite outcome of early mortality and morbidity [Time frame: 7 days]
- Highest level of resuscitation received in the delivery room [Time frame: First hour of life]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- Providence Alaska Medical Center — Anchorage
- Bartlett Regional Hospital — Juneau
- PeaceHealth Ketchikan Medical Center — Ketchikan
- Mayo Clinic Arizona — Pheonix
- Mayo Clinic Minnesota — Rochester
- Chickasaw Nation Medical Center — Ada
- Jackson County Memorial Hospital — Altus
- Great Plains Regional Medical Center — Elk City
- … and 13 more centers
Canada · 15 centers
- Stevenson Memorial Hospital — Alliston
- William Osler Health System - Brampton Civic Hospital — Brampton
- Michael Garron Hospital — East York
- William Osler Health System - Etobicoke General Hospital — Etobicoke
- Trillium Health Partners - Credit Valley Health — Mississauga
- Southlake Regional Health Centre — Newmarket
- Orillia Soldiers Memorial Hospital — Orillia
- Scarborough Health Network - Centenary Hospital — Scarborough Village
- … and 7 more centers
Publications
- Fang JL, Umoren R, Whyte H, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Colby CE, Herrin J, Jacobson RM, Demaerschalk BM. Provider Perspectives on the Acceptability, Appropriateness, and Feasibility of Teleneonatology. Am J Perinatol. 2023 Oct;40(14):1521-1528. doi: 10.1055/a-1656-6363. Epub 2021 Sep 28. PMID 34583392
- Fang JL, Whyte H, Umoren R, Limjoco J, Makkar A, Yankanah R, McCoy M, Lo MD, Herrin J, Demaerschalk BM. Accuracy of Simulated Research Tasks by Community Hospitals Participating in a Multicenter Telemedicine Trial. Telemed J E Health. 2022 Oct;28(10):1489-1495. doi: 10.1089/tmj.2021.0574. Epub 2022 Feb 15. PMID 35167373
- Fang JL, Umoren RA, Whyte H, Limjoco J, Makkar A, Behl S, Lo MD, White L, Culjat M, Taylor JS, Kathuria S, Webb MO, Schad T, Shafranski S, Yankanah R, Herrin J, Demaerschalk BM. Evaluating the feasibility of a multicenter teleneonatology clinical effectiveness trial. Pediatr Res. 2023 Oct;94(4):1555-1561. doi: 10.1038/s41390-023-02659-2. Epub 2023 May 19. PMID 37208433
Identifiers
NCT: NCT06087224 · 23-005502 · R01HD112327