Recruiting

Postnatal Steroids

Sponsor:

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

Code:

NCT04644094

Conditions

Left Ventricular Hypertrophy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Conditions

Left Ventricular Hypertrophy

Study ID

NCT04644094

Start date

Jun 15, 2021

Status verified date

Jun, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores) [ Time Frame: At the time of echocardiography ]
  • Lung water content [ Time Frame: At the time of echocardiography ]

Central Contacts and Locations

Central contacts

Gabriel Altit

5144124453gabriel.altit@mcgill.ca

Jessica Simoneau

5144124453jessica.simoneau@muhc.mcgill.ca

Locations

Montreal Children's hospital, Mcgill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Gabriel Altit, MD

514-412-4452gabriel.altit@mail.mcgill.ca

More Information

Sponsor

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

Last update posted

Jun 17, 2025

Last verified

Jun, 2025

Keywords

  • Lung ultrasound
  • Echocardiography
  • Heart rate variability
  • Left ventricular hypertrophy
  • Ductus arteriosus
  • Dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-06-17.