"Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •< 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.
排除标准
- •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
结局指标
主要结局
Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)
时间窗: At the time of echocardiography
The effects of dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27) 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer
Lung water content
时间窗: At the time of echocardiography
Lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the specified time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer
次要结局
- LV and RV function by strain(At the time of echocardiography)
- LV ejection fraction(At the time of echocardiography)
- Measures of PDA significance(At the time of echocardiography)
- Growth trajectory(At the time of the last echocardiography)
- BPD(At the study completion (12 months))
- RV function by TAPSE(At the time of echocardiography)
- Responders and non responders to Dexamethasone(At the study completion (12 months))
- Left ventricular (LV) output(At the time of echocardiography)
- Cortisol levels(At the study completion (12 months))
- Mortality(At the study completion (12 months))
- Ductal size(At the time of echocardiography)
- LV mass by STE(At the time of echocardiography)
- Strain and 3D values(At the time of echocardiography)
- Heart rate variability(At the time of echocardiography)
- Doppler flow velocities(At the time of echocardiography)
研究者
Gabriel Altit
Neonatologist
McGill University Health Centre/Research Institute of the McGill University Health Centre