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Идёт набор NCT04644094

Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

— Наблюдательное Left Ventricular Hypertrophy

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 (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration.
Кому может быть актуально
Состояния в реестре: Left Ventricular Hypertrophy. Базовые параметры: от 1 Minute · 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
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Официальное название

"Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."

Обзор

Hypothesis/Study question In infants born at less than 29 weeks of estimated gestational age, what are the effects of dexamethasone use on cardiac structure/performance and lung water content? Study objectives To measure effects before and after dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27) and lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the pre specified time points. Methodology / Study design Single center, prospective observational cohort study planning to enroll eligible patients over a period of 12 months

Подробное описание

This study investigates the effects of dexamethasone on cardiac structure/performance and lung water content in the extremely preterm population undergoing treatment for significant lung disease. For that, the specific aims are to determine the occurrence, evolution over time and possible hemodynamic impact of left ventricular hypertrophy and occurrence and degree of water retention in premature lungs, after dexamethasone administration. As secondary outcomes, this study also investigates the effects of dexamethasone on the ductus arteriosus, body growth, and autonomic regulation heart rate variability, as well as other important outcomes outlined in this protocol.

This study hypothesize that in some infants dexamethasone will be associated with the occurrence of early and/or prolonged left ventricular hypertrophy, which may be associated with changes in cardiac performance. It also hypothesize that the anti-inflammatory effects of dexamethasone would improve inflammation of immature lungs, leading to a decrease in interstitial fluid.

Вмешательства

  • Другое Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration
    A. Electrocardiographic (ECG) leads will be place in the patient for electrocardiogram (ECG) recordings. B. Echocardiography (ECHO) will be performed by an expert member of the Neonatal Echocardiography team C. Heart Rate Variability (HRV): ECG recordings D. Growth trajectory: body weight, length, head circumference, length/weight ratio at 1-, 2-weeks prior treatment, 1-, 2-, 3-, 4-,6-,8-weeks after treatment, at 36-week PMA.

Первичные конечные точки

  • Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores) [Срок оценки: At the time of echocardiography]
  • Lung water content [Срок оценки: At the time of echocardiography]
Вторичные конечные точки (12)
  • Left ventricular (LV) output [Срок оценки: At the time of echocardiography]
  • LV and RV function by strain [Срок оценки: At the time of echocardiography]
  • LV ejection fraction [Срок оценки: At the time of echocardiography]
  • Ductal size [Срок оценки: At the time of echocardiography]
  • Doppler flow velocities [Срок оценки: At the time of echocardiography]
  • Measures of PDA significance [Срок оценки: At the time of echocardiography]
  • LV mass by STE [Срок оценки: At the time of echocardiography]
  • RV function by TAPSE [Срок оценки: At the time of echocardiography]
  • Strain and 3D values [Срок оценки: At the time of echocardiography]
  • Heart rate variability [Срок оценки: At the time of echocardiography]
  • Growth trajectory [Срок оценки: At the time of the last echocardiography]
  • Cortisol levels [Срок оценки: At the study completion (12 months)]

Критерии участия

Критерии включения

  • < 29 weeks of gestational age at birth admitted at the McGill University Children Hospital's neonatal intensive care unit
  • To be initiated on dexamethasone therapy for treatment of significant lung disease as per medical team decision.

Критерии исключения

  • Congenital heart disease (except: Atrial septum defect (ASD), Ventricular septum defect (VSD)
  • Major congenital anomalies/genetic disorder (Trisomy 13, 18, 21)
  • Congenital severe lung or airway malformation (Trachea-esophageal fistula, congenital pulmonary airway malformation, congenital diaphragmatic hernia)
  • Twin-twin transfusion syndrome

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Montreal Children's hospital, Mcgill University Health Centre — Montreal

Идентификаторы

NCT: NCT04644094 · 2021-7305

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗