Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

NCT04644094 | Recruiting

• 1 other identifier: 2021-7305
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)

  The effects of dexamethasone administration on cardiac structure/performance will be evaluated by using the M-mode technique (Devereux method (25-27) 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer

  At the time of echocardiography

• Lung water content

  Lung water content will be specifically determined by the degree of water retention in premature lungs assessed by lung ultrasound at the specified time points: 0 day (before the start of dexamethasone), 3- , 7-day of treatment, 14-day of treatment if still receiving dexamethasone, and 1-week, 2-weeks after dexamethasone discontinuation, and finally at 35 - 37 weeks post menstrual age (PMA) or prior to discharge/transfer

  At the time of echocardiography

Secondary Outcomes (15)

• Left ventricular (LV) output

  At the time of echocardiography

• LV and RV function by strain

  At the time of echocardiography

• LV ejection fraction

  At the time of echocardiography

• Ductal size

  At the time of echocardiography

• Doppler flow velocities

  At the time of echocardiography

Interventions

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

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.

Eligibility Criteria

• Age: 1 Minute+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Extreme premature babies (\< 29 weeks of gestational age at birth) undergoing first treatment with dexamethasone for significant lung disease at the neonatal intensive care.

You may qualify if:

• \< 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Montreal Children's hospital, Mcgill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Hypertrophy, Left Ventricular; Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Gabriel Altit, MD

  Montreal Children's hospital, MUHC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Altit

CONTACT

5144124453; gabriel.altit@mcgill.ca

Jessica Simoneau

CONTACT

5144124453; jessica.simoneau@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 25, 2020
• Study Start: June 15, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)