The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Teleneonatology.
- Кому может быть актуально
- Состояния в реестре: Death; Neonatal, Morbidity;Newborn. Базовые параметры: от 0 Days · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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.
Первичные конечные точки
- 7-day mortality rate [Срок оценки: 7 days]
Вторичные конечные точки (3)
- Early neonatal morbidity within the first 7 days [Срок оценки: 7 days]
- Composite outcome of early mortality and morbidity [Срок оценки: 7 days]
- Highest level of resuscitation received in the delivery room [Срок оценки: First hour of life]
Критерии участия
Критерии включения
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.
Критерии исключения
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 21 центр
- 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
- … и ещё 13 центров
Канада · 15 центров
- 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
- … и ещё 7 центров
Публикации
- 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
Идентификаторы
NCT: NCT06087224 · 23-005502 · R01HD112327