RecruitingNCT04644094

Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

21 participants

Start Date

Jun 15, 2021

Study Type

OBSERVATIONAL

Conditions

Left Ventricular Hypertrophy

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

Eligibility

Min Age: 1 Minute

Inclusion Criteria2

< 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 Criteria4

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

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Interventions

OTHEREchocardiography (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(1)

Montreal Children's hospital, Mcgill University Health Centre

Montreal, Quebec, Canada

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