Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

Left Ventricular Hypertrophy Clinical Trial

— SPEC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644094
• Other study ID #: 2021-7305
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Gabriel Altit
• Phone: 5144124453
• Email: gabriel.altit[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

This study investigates the effects of dexamethasone on cardiac structure/performance and lung water content in the extremely preterm population undergoing treatment for significant lung disease. For that, the specific aims are to determine the occurrence, evolution over time and possible hemodynamic impact of left ventricular hypertrophy and occurrence and degree of water retention in premature lungs, after dexamethasone administration. As secondary outcomes, this study also investigates the effects of dexamethasone on the ductus arteriosus, body growth, and autonomic regulation heart rate variability, as well as other important outcomes outlined in this protocol.

This study hypothesize that in some infants dexamethasone will be associated with the occurrence of early and/or prolonged left ventricular hypertrophy, which may be associated with changes in cardiac performance. It also hypothesize that the anti-inflammatory effects of dexamethasone would improve inflammation of immature lungs, leading to a decrease in interstitial fluid.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
Canada	Montreal Children's hospital, Mcgill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	At the time of echocardiography
Secondary	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	At the time of echocardiography
Secondary	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	At the time of echocardiography
Secondary	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	At the time of echocardiography
Secondary	Doppler flow velocities	The effects of dexamethasone administration on: The Doppler flow velocities measured 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	At the time of echocardiography
Secondary	Measures of PDA significance	The effects of dexamethasone administration on: LA:AO (left atrium: aorta) Resistance index (RI) of the Anterior Cerebral Artery Direction of ductal flow Peak velocity of PDA in systole; 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	LV mass by STE	LV mass calculation using Speckle tracking echocardiography (STE) on the 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	At the time of echocardiography
Secondary	RV function by TAPSE	The effects of dexamethasone administration on: Tricuspid annular plane systolic excursion measurement by M-Mode 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	At the time of echocardiography
Secondary	Strain and 3D values	The effects of dexamethasone administration on: RV and LV strains and on the cardiac volumes by 3 D (RV and LV) by echocardiography acquired images, using Tomtec platform for post treatment; 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	Heart rate variability	The effects of dexamethasone administration on heart rate variability by ECG; 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	Growth trajectory	The effects of dexamethasone administration on growth trajectory (body, length, head circumference, L/W ratio) at 1-,2-weekks prior treatment and 1-,2-,3-,4-,6-,8- weeks after treatment, and finally at 36 weeks PMA	At the time of the last echocardiography
Secondary	Cortisol levels	The effects of dexamethasone after administration: Cortisol levels in nmol/L	At the study completion (12 months)
Secondary	BPD	The effects of dexamethasone administration on: -BPD rate (%) (2018 NICHD definition)	At the study completion (12 months)
Secondary	Mortality	- Rate of death in this high risk population (%)	At the study completion (12 months)
Secondary	Responders and non responders to Dexamethasone	We will analyze the rate (%) of responders and non-responders to Dexamethasone. Responders: Defined by decreasing Respiratory Severity Scores (RSS) by 40% at day 6 of Dexamethasone treatment or before. RSS is calculated by using maximum of mean airway pressure (MAP) multiplied by fractional oxygen (FiO2) at the day of the first dose of Dexamethasone administration (Day 0)	At the study completion (12 months)