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

Morbidity;Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087224
• Other study ID #: 23-005502
• Secondary ID: R01HD112327
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: October 1, 2028

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: Jennifer Fang, MD, MS
• Phone: 5072669397
• Email: fang.jennifer[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 947
• Est. completion date: October 1, 2028
• Est. primary completion date: August 7, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Death; Neonatal
• Morbidity;Newborn

Intervention

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.

Locations

Country	Name	City	State
United States	Jackson County Memorial Hospital	Altus	Oklahoma
United States	Island Health	Anacortes	Washington
United States	Prairie Ridge Health	Columbus	Wisconsin
United States	Great Plains Regional Medical Center	Elk City	Oklahoma
United States	Providence Regional Medical Center Everett	Everett	Washington
United States	Fort HealthCare	Fort Atkinson	Wisconsin
United States	Bartlett Regional Hospital	Juneau	Alaska
United States	PeaceHealth Ketchikan Medical Center	Ketchikan	Alaska
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	Olympic Medical Center	Port Angeles	Washington
United States	Sauk Prairie Healthcare	Prairie Du Sac	Wisconsin
United States	Reedsburg Area Medical Center	Reedsburg	Wisconsin
United States	Mayo Clinic Minnesota	Rochester	Minnesota
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Watertown Regional Medical Center	Watertown	Wisconsin
United States	Central Washington Health Services Association d/b/a Confluence Health	Wenatchee	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials