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Recruiting NCT04644094

Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

— Observational Left Ventricular Hypertrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration.
Who it may be relevant to
Registry conditions: Left Ventricular Hypertrophy. Basic parameters: from 1 Minute · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed 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.

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.

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Left ventricular (LV) output [Time frame: At the time of echocardiography]
  • LV and RV function by strain [Time frame: At the time of echocardiography]
  • LV ejection fraction [Time frame: At the time of echocardiography]
  • Ductal size [Time frame: At the time of echocardiography]
  • Doppler flow velocities [Time frame: At the time of echocardiography]
  • Measures of PDA significance [Time frame: At the time of echocardiography]
  • LV mass by STE [Time frame: At the time of echocardiography]
  • RV function by TAPSE [Time frame: At the time of echocardiography]
  • Strain and 3D values [Time frame: At the time of echocardiography]
  • Heart rate variability [Time frame: At the time of echocardiography]
  • Growth trajectory [Time frame: At the time of the last echocardiography]
  • Cortisol levels [Time frame: At the study completion (12 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Montreal Children's hospital, Mcgill University Health Centre — Montreal

Identifiers

NCT: NCT04644094 · 2021-7305

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗