Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
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: Echocardiography.
- Кому может быть актуально
- Состояния в реестре: Congenital Diaphragmatic Hernia. Базовые параметры: до 17 лет · 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
- Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
ECHO-CDH - Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
Обзор
CDH is associated with lung hypoplasia, pulmonary hypertension, and left ventricular hypoplasia. Use of new STE techniques (heart ultrasound) showed that CDH newborns have decreased LV size and function, potentially explaining the non-response to iNO, and that these cardiac findings were associated with poor outcomes. Our hypothesis: CDH newborns persist to have some degree of LV hypoplasia in the pediatric and adolescent life and pulmonary pressures remain increased during growth. Patients with decreased cardiac performance by STE and/or with PH have higher concomitant neonatal or pediatric morbidities and altered neurodevelopmental profile
Подробное описание
The principal investigator hypothesize that CDH newborns have disturbed cardiac performance and increased pulmonary pressures during neonatal life and at different pediatric ages. The principal investigator also postulate that those with decreased cardiac performance by STE and/or with PH have higher concomitant neonatal or pediatric morbidities and altered neurodevelopmental profile, that CDH patients have some remaining degree of LV hypoplasia at pediatric/adolescent age and that novel echocardiography techniques will detect anomalies not uncovered by conventional imaging.
This study is a prospective study. Cohorts will be simultaneously recruited at different neonatal and pediatric ages to create various age groups of the CDH populations.
Groups will be synchronized with the current follow-up programs to ease feasibility.
Patient Population will be CDH patients admitted to the NICU at the MCH or followed in the clinic. Patients will be recruited during hospitalization or at the different age groups corresponding to their regular CDH follow-up.
Echocardiography will be targeted to acquire: RV and LV function by STE, 3D derived RV/LV volumes and performance , conventional systolic/diastolic RV and LV function parameters (such as: ejection fraction by Simpson's Biplane, tricuspid annular plane systolic excursion and tissue Doppler velocities), cardiac outputs and pulmonary pressure estimates. For patient's safety, responsible clinician will be alerted when a clinically significant anomaly is detected on the research echocardiography. Same echocardiography protocol will be applied to controls.
Associated to echocardiography data, The principal investigator will complete a chart review to extract important neonatal/pediatric demographic and clinical data. Variables extracted, among others, will include perinatal details (mode of delivery, maternal conditions, APGAR scores), sex, birth weight, clinical course and major morbidities. Bayley Scales of Infant and Toddler Development - Third Edition, a standardized evaluation for motor, cognitive and language abilities, is done on all patients with CDH at 18 months PMA at the MCH. When available for age groups beyond 18 months of age, these scores will be recorded. As well, assessment tools describing functional and developmental status will be filled with parents (or legal guardian) and/or pre-adolescents/adolescents. These tools will be the: Ages \& Stages Questionnaires 3 (a parent report of developmental skills for ages of 2 to 60 months , the Clinical Adaptive Test /Clinical Linguistic Auditory Milestone Scale (CAT/CLAMS), which has a high correlation with the Bayley Scales of Infant Development and is a neurodevelopmental assessment tool of infants and toddlers) and the Pediatric Quality of Life Inventory Survey (a pre-adolescent and adolescent report on quality of life and functional status).
Patients with CDH will be compared to controls (1:1) recruited contemporaneously. Clinics targeted for control groups include the dermatology, orthopedic, trauma follow-up and neurology clinic for benign seizures episodes.
Вмешательства
- Другое Echocardiography
Echocardiography has become routinely used in the diagnosis, management, and follow-up of patients with any suspected or known heart diseases. It is one of the most widely used diagnostic tests in cardiology. It can provide a wealth of helpful information, including the size and shape of the heart (internal chamber size quantification), pumping capacity, and the location and extent of any tissue damage. An echocardiogram can also give physicians other estimates of heart function, such as a calcu
Первичные конечные точки
- Assessment of cardiac function [Срок оценки: Within 24 hours of life]
- Assessment of cardiac function [Срок оценки: Between day 3 to 5 of life]
- Assessment of cardiac function [Срок оценки: Between 2 to 3 weeks of life]
- Assessment of cardiac function [Срок оценки: age of 4 and/or 9 months]
- Assessment of cardiac function [Срок оценки: 3, 5 and/or 8 years]
- Assessment of cardiac function [Срок оценки: 11, 14 and/or 17 years]
Вторичные конечные точки (6)
- Prevalence of pulmonary hypertension [Срок оценки: Within 24 hours of life]
- Prevalence of pulmonary hypertension [Срок оценки: Between day 3 to 5 of life]
- Prevalence of pulmonary hypertension [Срок оценки: Between 2 to 3 weeks of life]
- Prevalence of pulmonary hypertension [Срок оценки: age of 4 and/or 9 months]
- Prevalence of pulmonary hypertension [Срок оценки: 3, 5 and/or 8 years]
- Prevalence of pulmonary hypertension [Срок оценки: 11, 14 and/or 17 years]
Критерии участия
Inclusion:
- CDH patients admitted to the MCH-NICU
- CDH followed at the MCH CDH clinic
Exclusion:
- Prematurity (< 36 weeks)
- Diagnosis at > 7 days of life
- Bilateral CDH
- Congenital cardiac defect (excluding a patent ductus arteriosus (PDA), atrial septal defect (ASD) or ventricular septal defect (VSD)) and/or other major anomaly/genetic syndrome.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Канада · 1 центр
- Mcgill University Health Centre — Montreal
Идентификаторы
NCT: NCT04114578 · 2020-4892