Clinical trial NCT06087224: The TELENEO Trial: a Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Official title: The TELENEO Trial: a Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Death; Neonatal
Morbidity;Newborn
Keywords: Telemedicine
Newborn
Resuscitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-10-17
Enrollment: 947
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: TREATMENT

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.

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:

1. A clinician 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 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:

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.

Primary outcomes:
measure: 7-day mortality rate
timeFrame: 7 days
Secondary outcomes:
measure: Early neonatal morbidity within the first 7 days
timeFrame: 7 days
measure: Composite outcome of early mortality and morbidity
timeFrame: 7 days
measure: Highest level of resuscitation received in the delivery room
timeFrame: First hour of life
Other outcomes:
Locations:
city: Juneau
country: United States
facility: Bartlett Regional Hospital
state: Alaska
city: Ketchikan
country: United States
facility: PeaceHealth Ketchikan Medical Center
state: Alaska
city: Pheonix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
city: Altus
country: United States
facility: Jackson County Memorial Hospital
state: Oklahoma
city: Elk City
country: United States
facility: Great Plains Regional Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Anacortes
country: United States
facility: Island Health
state: Washington
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Port Angeles
country: United States
facility: Olympic Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health
state: Washington
city: Columbus
country: United States
facility: Prairie Ridge Health
state: Wisconsin
city: Fort Atkinson
country: United States
facility: Fort HealthCare
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Prairie du Sac
country: United States
facility: Sauk Prairie Healthcare
state: Wisconsin
city: Reedsburg
country: United States
facility: Reedsburg Area Medical Center
state: Wisconsin
city: Watertown
country: United States
facility: Watertown Regional Medical Center
state: Wisconsin
city: Alliston
country: Canada
facility: Stevenson Memorial Hospital
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health System - Brampton Civic Hospital
state: Ontario
city: East York
country: Canada
facility: Michael Garron Hospital
state: Ontario
city: Etobicoke
country: Canada
facility: William Osler Health System - Etobicoke General Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners - Credit Valley Health
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Orillia
country: Canada
facility: Orillia Soldiers Memorial Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network - Centenary Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network - General Hospital
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Unity Health - St. Joseph's Health Centre
state: Ontario
city: Vaughan
country: Canada
facility: Mackenzie Health - Cortellucci Vaughan Hospital
state: Ontario
Study officials:
affiliation: Mayo Clinic
name: Jennifer Fang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Bart M Demaerschalk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Meegan G Van Straaten, MSPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.