Clinical trial Recruiting at 1 site Observational Ages 1 Minute and up

Effects of Dexamethasone on Heart Function in Extremely Preterm Infants

Official title: "Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."

Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT04644094 · Data updated 2026-11-12

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 typeObservational
Ages1 Minute and up
SexAll
Enrollment21 (estimated)
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Academic / other
Locations1 site (Montreal, Quebec)
StatusRecruiting
StartedJune 15, 2021
Main results expectedFebruary 2026
Study endsJune 2026
Registry record updatedJune 17, 2025
Trial IDNCT04644094 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants born at less than 29 weeks of gestational age who are starting dexamethasone therapy for significant lung disease.

Probably not a fit

Patients with congenital heart disease or major congenital anomalies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Montreal Children's hospital, Mcgill University Health Centre
    Montreal, Quebec, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.