Effects of Dexamethasone on Heart Function in Extremely Preterm Infants
"Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."
This study looks at how the medication dexamethasone affects heart function and lung fluid in extremely preterm infants born before 29 weeks to see if it helps improve their health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 21 (estimated) |
| Ages | 1 Minute and up |
| Sex | All |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT04644094 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how dexamethasone affects cardiac structure and performance, as well as lung water content, in infants born at less than 29 weeks of gestational age. It aims to measure changes in left ventricular hypertrophy and lung fluid retention before and after dexamethasone administration using echocardiography and lung ultrasound. The study will enroll eligible patients over a 12-month period at a single center, focusing on the hemodynamic impact of dexamethasone in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are infants born at less than 29 weeks of gestational age who are starting dexamethasone therapy for significant lung disease.
Not a fit: Patients with congenital heart disease or major congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of cardiac and respiratory complications in extremely preterm infants.
How similar studies have performed: While similar studies have explored the effects of dexamethasone in preterm infants, this specific focus on cardiac function and lung water content is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montreal, Quebec
- Montreal Children's hospital, Mcgill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Gabriel Altit, MD — Montreal Children's hospital, MUHC
- Study coordinator: Gabriel Altit
- Email: gabriel.altit@mcgill.ca
- Phone: 5144124453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.