Dynamic Critical Congenital Heart Screening With Addition of Perfusion Measurements
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: SpO2/PIx Measurement and ML Algorithm.
- Кому может быть актуально
- Состояния в реестре: Congenital Heart Disease. Базовые параметры: 0 Minutes — 21 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
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Обзор
The purpose of this study is to implement and externally validate an inpatient ML algorithm that combines pulse oximetry features for critical congenital heart disease (CCHD) screening.
Подробное описание
The study will externally validate an algorithm that combines non-invasive oxygenation and perfusion measurements as a screening tool for CCHD. In a previous study, the investigators created an algorithm that combines non-invasive measurements of oxygenation and perfusion over at least two measurements using machine learning (ML) techniques. The prior model was created and tested using internal validation (k-fold validation). Thus, the investigators will test the model on an external sample of patients to test generalizability of the model. Additionally, the team will trial a repeated measurement for any "failure" of the screen to assess impact on the false positive rate. Study team will also use repeated pulse oximetry measurements (up to 4 total and including measurements after 48 hours of age, which may be done outpatient) to create a new algorithm that incorporates new data over time. The central hypothesis is that the addition of non-invasive perfusion measurements will be superior to SpO2-alone screening for CCHD detection and a model that incorporates repeated measurements will enhance detection of CCHD while preserving the specificity.
Вмешательства
- Диагностический тест SpO2/PIx Measurement and ML Algorithm
Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured and an online ML inference model will be used to classify a newborn as healthy versus CCHD as new pulse oximetry data is collected.
Первичные конечные точки
- Area under the curve for receiver operating characteristics for critical congenital heart disease using ML inpatient algorithm. [Срок оценки: Through study completion, an average of 4 years]
Вторичные конечные точки (6)
- Sensitivity for critical congenital heart disease using ML inpatient algorithm (0-24 hours and 24-48 hours) [Срок оценки: Through study completion, an average of 4 years]
- Specificity for critical congenital heart disease using ML inpatient algorithm (0-24 hours and 24-48 hours) [Срок оценки: Through study completion, an average of 4 years]
- Area under the curve for receiver operating characteristics for critical congenital heart disease using dynamic ML algorithm [Срок оценки: Through study completion, an average of 4 years]
- Sensitivity for critical congenital heart disease using dynamic ML algorithm [Срок оценки: Through study completion, an average of 4 years]
- Specificity for critical congenital heart disease using dynamic ML model [Срок оценки: Through study completion, an average of 4 years]
- Sensitivity for critical coarctation of the aorta using dynamic ML algorithm [Срок оценки: Through study completion, an average of 4 years]
Критерии участия
Критерии включения
- Age < 22 days
- Fetuses suspected to have congenital heart disease
- Newborns with suspected/confirmed critical congenital heart disease
- Asymptomatic newborn undergoing SpO2 screening for CCHD
Критерии исключения
- Echocardiogram completed prior to enrollment as the newborn would then no longer be considered "asymptomatic undergoing SpO2 screening for CCHD"
- For Newborns with confirmed/suspected congenital heart disease (CHD): a) Patent ductus arteriosus and/or atrial septal defect/patent foramen ovale without other defects, b) Corrective cardiac surgical or catheter intervention performed before enrollment or c) Current infusions of vasoactive medications other than prostaglandin therapy.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
США · 3 центра
- UC Davis Medical Center — Davis
- Cohen Children's Medical Center — Queens
- University of Utah Health Care — Salt Lake City
Идентификаторы
NCT: NCT05637814 · 1933258