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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD112327 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teleneonatology group | Experimental | Study eligible neonates cared for by the community hospital team with telemedicine consultation by a neonatologist from the regional neonatal intensive care unit (NICU). |
|
| Control group | No Intervention | Study eligible neonates cared for by the community hospital team per the site's usual practice of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleneonatology | Other | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
GROUP 1: Community hospital clinicians
To be eligible to participate in this study, an individual must meet all of the following criteria:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Fang, MD, MS | Contact | 5072669397 | fang.jennifer@mayo.edu | |
| Bart M Demaerschalk, MD, MSc | Contact | 4803018000 | demaerschalk.bart@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Fang, MD | Mayo Clinic | Principal Investigator |
| Bart M Demaerschalk, MD | Mayo Clinic | Principal Investigator |
| Meegan G Van Straaten, MSPH |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Alaska Medical Center | Recruiting | Anchorage | Alaska | 99508 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34583392 | Background | 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. | |
| 35167373 | Background | 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. |
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Stepped wedge cluster randomized trial
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| 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 |
| 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 |
| Mayo Clinic |
| Study Director |
| Bartlett Regional Hospital | Recruiting | Juneau | Alaska | 99801 | United States |
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| PeaceHealth Ketchikan Medical Center | Recruiting | Ketchikan | Alaska | 99901 | United States |
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| Mayo Clinic Arizona | Active, not recruiting | Pheonix | Arizona | 85054 | United States |
| Mayo Clinic Minnesota | Active, not recruiting | Rochester | Minnesota | 55905 | United States |
| Chickasaw Nation Medical Center | Recruiting | Ada | Oklahoma | 74820 | United States |
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| Jackson County Memorial Hospital | Recruiting | Altus | Oklahoma | 73521 | United States |
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| Great Plains Regional Medical Center | Recruiting | Elk City | Oklahoma | 73648 | United States |
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| University of Oklahoma Health Sciences Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Island Health | Recruiting | Anacortes | Washington | 98221 | United States |
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| Providence Regional Medical Center Everett | Recruiting | Everett | Washington | 98201 | United States |
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| Olympic Medical Center | Recruiting | Port Angeles | Washington | 98362 | United States |
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| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
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| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
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| Central Washington Health Services Association d/b/a Confluence Health | Recruiting | Wenatchee | Washington | 98801 | United States |
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| Prairie Ridge Health | Recruiting | Columbus | Wisconsin | 53925 | United States |
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| Fort HealthCare | Recruiting | Fort Atkinson | Wisconsin | 53538 | United States |
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| University of Wisconsin-Madison | Recruiting | Madison | Wisconsin | 53715 | United States |
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| Sauk Prairie Healthcare | Recruiting | Prairie du Sac | Wisconsin | 53578 | United States |
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| Reedsburg Area Medical Center | Recruiting | Reedsburg | Wisconsin | 53959 | United States |
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| Watertown Regional Medical Center | Recruiting | Watertown | Wisconsin | 53098 | United States |
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| Stevenson Memorial Hospital | Recruiting | Alliston | Ontario | L9R 1W7 | Canada |
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| William Osler Health System - Brampton Civic Hospital | Recruiting | Brampton | Ontario | L6R 3J7 | Canada |
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| Michael Garron Hospital | Recruiting | East York | Ontario | M4C 3E7 | Canada |
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| William Osler Health System - Etobicoke General Hospital | Recruiting | Etobicoke | Ontario | M9V 1R8 | Canada |
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| Trillium Health Partners - Credit Valley Health | Recruiting | Mississauga | Ontario | L5M 2N1 | Canada |
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| Southlake Regional Health Centre | Recruiting | Newmarket | Ontario | L3Y 2P9 | Canada |
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| Orillia Soldiers Memorial Hospital | Recruiting | Orillia | Ontario | L3V 2Z3 | Canada |
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| Scarborough Health Network - Centenary Hospital | Recruiting | Scarborough Village | Ontario | M1E 4B9 | Canada |
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| Scarborough Health Network - General Hospital | Recruiting | Scarborough Village | Ontario | M1P 2V5 | Canada |
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| North York General Hospital | Recruiting | Toronto | Ontario | M2K 1E1 | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | M4N 3M5 | Canada |
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| Mount Sinai Hospital | Recruiting | Toronto | Ontario | M5G 1X5 | Canada |
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| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
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| Unity Health - St. Joseph's Health Centre | Recruiting | Toronto | Ontario | M6R 1B5 | Canada |
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| Mackenzie Health - Cortellucci Vaughan Hospital | Recruiting | Vaughan | Ontario | L6A 4Z3 | Canada |
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| 37208433 | Background | 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. |
| ID | Term |
|---|---|
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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