An observational study in Left Ventricular Hypertrophy, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 1 Minute and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational
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
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.
162 studies on the registry are indexed under Hypertrophy, Left Ventricular; 28 are open to participants now.
This study's planned enrollment of 21 is below the median of 198 across 60 observational studies indexed under Hypertrophy, Left Ventricular.
Browse Hypertrophy, Left Ventricular studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
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Extreme premature babies (\< 29 weeks of gestational age at birth) undergoing first treatment with dexamethasone for significant lung disease at the neonatal intensive care.
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Exclusion Criteria:
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.
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
Time frame: At the time of echocardiography
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
Time frame: At the time of echocardiography
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
Time frame: At the time of echocardiography
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
Time frame: At the time of echocardiography
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
Time frame: At the time of echocardiography
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
Time frame: At the time of echocardiography
Doppler flow velocities
The effects of dexamethasone administration on: The Doppler flow velocities measured 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
Time frame: At the time of echocardiography
Measures of PDA significance
The effects of dexamethasone administration on: LA:AO (left atrium: aorta) Resistance index (RI) of the Anterior Cerebral Artery Direction of ductal flow Peak velocity of PDA in systole 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
Time frame: At the time of echocardiography
LV mass by STE
LV mass calculation using Speckle tracking echocardiography (STE) on the 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
Time frame: At the time of echocardiography
RV function by TAPSE
The effects of dexamethasone administration on: Tricuspid annular plane systolic excursion measurement by M-Mode 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
Time frame: At the time of echocardiography
Strain and 3D values
The effects of dexamethasone administration on: RV and LV strains and on the cardiac volumes by 3 D (RV and LV) by echocardiography acquired images, using Tomtec platform for post treatment 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
Time frame: At the time of echocardiography
Heart rate variability
The effects of dexamethasone administration on heart rate variability by ECG 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
Time frame: At the time of echocardiography
Growth trajectory
The effects of dexamethasone administration on growth trajectory (body, length, head circumference, L/W ratio) at 1-,2-weekks prior treatment and 1-,2-,3-,4-,6-,8- weeks after treatment, and finally at 36 weeks PMA
Time frame: At the time of the last echocardiography
Cortisol levels
The effects of dexamethasone after administration: Cortisol levels in nmol/L
Time frame: At the study completion (12 months)
BPD
The effects of dexamethasone administration on: -BPD rate (%) (2018 NICHD definition)
Time frame: At the study completion (12 months)
Mortality
- Rate of death in this high risk population (%)
Time frame: At the study completion (12 months)
Responders and non responders to Dexamethasone
We will analyze the rate (%) of responders and non-responders to Dexamethasone. Responders: Defined by decreasing Respiratory Severity Scores (RSS) by 40% at day 6 of Dexamethasone treatment or before. RSS is calculated by using maximum of mean airway pressure (MAP) multiplied by fractional oxygen (FiO2) at the day of the first dose of Dexamethasone administration (Day 0)
Time frame: At the study completion (12 months)
Plan to share: No
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Hypertrophy, Left Ventricular →
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