Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-15

Study Completion Date

2026-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Left Ventricular Hypertrophy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No