Left Ventricular HypertrophySPECNCT04644094
Postnatal Steroids Effects on Cardiac Function in Extremely Preterm
An observational study of Left Ventricular Hypertrophy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 minute and older
- Conditions the study is for
- Left Ventricular Hypertrophy
- What is being tested?
- Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2021to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- < 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal Children's hospital, Mcgill University Health Centre
Montreal, Quebec, H4A 3J1
Gabriel Altit, MD, 514-412-4452, gabriel.altit@mail.mcgill.ca
About this study
Official title: "Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."
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
Read the detailed description
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.
- Conditions
- Left Ventricular Hypertrophy
- Being tested
- Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration
- Keywords
- Lung ultrasound, Echocardiography, Heart rate variability, Left ventricular hypertrophy, Ductus arteriosus, Dexamethasone
- Medical subject headings
- Hypertrophy, Left Ventricular, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administrationOther
- Electrocardiographic (ECG) leads will be place in the patient for electrocardiogram (ECG) recordings.
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At the time of echocardiography
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the time of the last echocardiography
Cortisol levels
The effects of dexamethasone after administration:
Cortisol levels in nmol/L
Measured: At the study completion (12 months)
BPD
The effects of dexamethasone administration on:
-BPD rate (%) (2018 NICHD definition)
Measured: At the study completion (12 months)
Mortality
- Rate of death in this high risk population (%)
Measured: 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)
Measured: At the study completion (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start15 Jun 2021
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Altit, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Gabriel Altit, MD, Principal investigator, Montreal Children's hospital, MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644094
- Sponsor's protocol ID
- 2021-7305
- Acronym
- SPEC
- Status last verified
- Jun 2025
- First submitted
- 9 Nov 2020
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."
- ClinicalTrials.gov ID
- NCT04644094
- Acronym / sponsor ID
- SPEC / 2021-7305
- Conditions
- Left Ventricular Hypertrophy
- Keywords
- Lung ultrasound, Echocardiography, Heart rate variability, Left ventricular hypertrophy, Ductus arteriosus, Dexamethasone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- < 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administrationA. 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. | Other | – |
Primary outcome
Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)
Time frame: 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
Time frame: 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
15 secondary outcomes
Left ventricular (LV) output
Time frame: At the time of echocardiography
LV and RV function by strain
Time frame: At the time of echocardiography
LV ejection fraction
Time frame: At the time of echocardiography
Ductal size
Time frame: At the time of echocardiography
Doppler flow velocities
Time frame: At the time of echocardiography
Measures of PDA significance
Time frame: At the time of echocardiography
LV mass by STE
Time frame: At the time of echocardiography
RV function by TAPSE
Time frame: At the time of echocardiography
Strain and 3D values
Time frame: At the time of echocardiography
Heart rate variability
Time frame: At the time of echocardiography
Growth trajectory
Time frame: At the time of the last echocardiography
Cortisol levels
Time frame: At the study completion (12 months)
BPD
Time frame: At the study completion (12 months)
Mortality
Time frame: At the study completion (12 months)
Responders and non responders to Dexamethasone
Time frame: At the study completion (12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel Altit, MD principal investigator
Montreal Children's hospital, MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Hypertrophy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Altit (5144124453, gabriel.altit@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores) (time frame: At the time of echocardiography). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.