NCT04644094 Postnatal Steroids Effects on Cardiac Function in Extremely Preterm
| NCT ID | NCT04644094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre |
| Condition | Left Ventricular Hypertrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 21 participants |
| Start Date | 2021-06-15 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 21 participants in total. It began in 2021-06-15 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Gabriel Altit, MD
PRINCIPAL INVESTIGATOR
Montreal Children's hospital, MUHC
Frequently Asked Questions
Who can join the NCT04644094 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, studying Left Ventricular Hypertrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04644094 currently recruiting?
Yes, NCT04644094 is actively recruiting participants. Contact the research team at gabriel.altit@mcgill.ca for enrollment information.
Where is the NCT04644094 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04644094 clinical trial?
NCT04644094 is sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. The principal investigator is Gabriel Altit, MD at Montreal Children's hospital, MUHC. The trial plans to enroll 21 participants.