RecruitingNot Applicable

Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

Canada21 participantsStarted 2021-06-15

Plain-language 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 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

Who can participate

Age range

1 Minute

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \< 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)

Timeframe: At the time of echocardiography

Lung water content

Timeframe: At the time of echocardiography

Trial details

NCT IDNCT04644094

SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02

Contact for this trial

Gabriel Altit

5144124453 gabriel.altit@mcgill.ca

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