Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

< 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.

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
At the time of echocardiography
2

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

Time frame
At the time of echocardiography

Secondary outcomes

1

Left ventricular (LV) output

The effects of dexamethasone administration on: On the LV output assessed by Doppler by echocardiography 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

Time frame
At the time of echocardiography
2

LV and RV function by strain

LV and RV function by strain by post treatment of echocardiography acquired images with a Tomtec platform 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

Time frame
At the time of echocardiography
3

LV ejection fraction

The effects of dexamethasone administration on: The ejection fraction measured by Simpson on a echocardiography. 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

Time frame
At the time of echocardiography
4

Ductal size

The effects of dexamethasone administration on the size patent ductus arteriosus (PDA) measured on the echocardiography 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

Time frame
At the time of echocardiography

Other outcomes

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