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Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

NCT04644094 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2025-06-17

No results posted yet for this study

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

Conditions

  • Left Ventricular Hypertrophy

Interventions

OTHER

Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration

A. 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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Gabriel Altit, MD · Montreal Children's hospital, MUHC

Eligibility

Min Age
1 Minute
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-15
Primary Completion
2026-02-28
Completion
2026-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04644094 on ClinicalTrials.gov