About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
< 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.
Disqualifiers
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
Trial population
Extreme premature babies (\< 29 weeks of gestational age at birth) undergoing first treatment with dexamethasone for significant lung disease at the neonatal intensive care.
Trial design
Cohort
Prospective
Treatments tested in this trial
Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration
Other interventionA. 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.
Treatment groups
Trial outcomes
Primary outcomes
Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)
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
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
Secondary outcomes
Left ventricular (LV) output
The effects of dexamethasone administration on: On the LV output assessed by Doppler by echocardiography 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
LV and RV function by strain
LV and RV function by strain by post treatment of echocardiography acquired images with a Tomtec platform 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
LV ejection fraction
The effects of dexamethasone administration on: The ejection fraction measured by Simpson on a echocardiography. 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
Ductal size
The effects of dexamethasone administration on the size patent ductus arteriosus (PDA) measured on the echocardiography 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
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