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

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.

Study Overview

• Status: Recruiting
• Conditions: Morbidity;Newborn; Death; Neonatal
• Intervention / Treatment: Other: Teleneonatology

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 Type: Interventional
• Enrollment (Estimated): 947
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Fang, MD, MS; Phone Number: 5072669397; Email: fang.jennifer@mayo.edu
• Study Contact Backup: Name: Bart M Demaerschalk, MD, MSc; Phone Number: 4803018000; Email: demaerschalk.bart@mayo.edu

Study Locations

• United States
  • Alaska
    • Juneau, Alaska, United States, 99801
      • Not yet recruiting
      • Bartlett Regional Hospital
      • Contact: Jessica Sperry, RN; Phone Number: 907-796-8657; Email: jmsperry@bartletthospital.org
    • Ketchikan, Alaska, United States, 99901
      • Not yet recruiting
      • PeaceHealth Ketchikan Medical Center
      • Contact: Kristin Fahey, RN
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Not yet recruiting
      • Mayo Clinic Arizona
      • Principal Investigator: Bart Demaerschalk, MD
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Mayo Clinic Minnesota
      • Principal Investigator: Jennifer Fang, MD
  • Oklahoma
    • Altus, Oklahoma, United States, 73521
      • Recruiting
      • Jackson County Memorial Hospital
      • Contact: Lindsey King, MD
    • Elk City, Oklahoma, United States, 73648
      • Not yet recruiting
      • Great Plains Regional Medical Center
      • Contact: Miranda Cummings, RN; Phone Number: 580-821-5326; Email: mcummings@gprmc-ok.com
    • Oklahoma City, Oklahoma, United States, 73104
      • Not yet recruiting
      • University of Oklahoma Health Sciences Center
      • Principal Investigator: Tavleen Sandhu, MD
  • Washington
    • Anacortes, Washington, United States, 98221
      • Recruiting
      • Island Health
      • Contact: Jason Hogge, MD
    • Everett, Washington, United States, 98201
      • Not yet recruiting
      • Providence Regional Medical Center Everett
      • Contact: Mihai Puia-Dumitrescu, MD, MPH
    • Port Angeles, Washington, United States, 98362
      • Not yet recruiting
      • Olympic Medical Center
      • Contact: Laura Bullen, MD
    • Seattle, Washington, United States, 98105
      • Not yet recruiting
      • Seattle Children's Hospital
      • Principal Investigator: Mark Lo, MD
    • Seattle, Washington, United States, 98195
      • Not yet recruiting
      • University of Washington
      • Principal Investigator: Rachel Umoren, MD
    • Wenatchee, Washington, United States, 98801
      • Not yet recruiting
      • Central Washington Health Services Association d/b/a Confluence Health
      • Contact: Brenda Baumeister, MD; Phone Number: 33131 509-662-1511; Email: brenda.baumeister@confluencehealth.org
  • Wisconsin
    • Columbus, Wisconsin, United States, 53925
      • Not yet recruiting
      • Prairie Ridge Health
      • Contact: Rachel Svendsen, RN; Phone Number: 920-623-1299; Email: rsvendsen@prairieridge.health
    • Fort Atkinson, Wisconsin, United States, 53538
      • Recruiting
      • Fort HealthCare
      • Contact: Deborah Schumacher, RN
    • Madison, Wisconsin, United States, 53715
      • Not yet recruiting
      • University of Wisconsin-Madison
      • Principal Investigator: Jamie Limjoco, MD
    • Prairie Du Sac, Wisconsin, United States, 53578
      • Recruiting
      • Sauk Prairie Healthcare
      • Contact: Todd Schad, MD
    • Reedsburg, Wisconsin, United States, 53959
      • Not yet recruiting
      • Reedsburg Area Medical Center
      • Contact: Anne Harris, MD
    • Watertown, Wisconsin, United States, 53098
      • Not yet recruiting
      • Watertown Regional Medical Center
      • Contact: Patricia Gedemer, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

GROUP 1: Community hospital physicians

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. A physician who attends newborn resuscitations at a participating community hospital spoke site.
2. 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

1. Preterm birth at less than 32 weeks' gestation at delivery; OR

2. Need for advanced resuscitation defined as:

   1. positive pressure ventilation (PPV) initiated soon after birth and continued for at least 10 minutes; OR
   2. placement of an alternative airway (endotracheal tube or laryngeal mask) to provide PPV; OR
   3. 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:

1. Birth outside of the hospital birthing center.
2. Neonatal transport team present at time of birth and providing resuscitative care.
3. Severe congenital anomaly necessitating intensive care or surgery in the first two weeks of life.
4. Plan for comfort care (non-resuscitation) following delivery.
5. In-person neonatology-trained physician present for the resuscitation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
No Intervention: Control group; Study eligible neonates cared for by the community hospital team per the site's usual practice of care.

What is the study measuring?

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
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
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	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 definite pneumothorax on chest imaging, severe intracranial hemorrhage on brain imaging, or seizures on electroencephalogram in the first seven days of life.	7 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Jennifer Fang, MD, Mayo Clinic; Principal Investigator: Bart M Demaerschalk, MD, Mayo Clinic; Study Director: Meegan G Van Straaten, MSPH, Mayo Clinic

Publications and helpful links

General 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.
• 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.
• 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): August 7, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Telemedicine; Newborn; Resuscitation
• Other Study ID Numbers: 23-005502; R01HD112327 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No