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RECRUITING
NCT04644094

Postnatal Steroids Effects on Cardiac Function in Extremely Preterm

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

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

1 Minute - Any

Study Type

OBSERVATIONAL

Enrollment

21

Start Date

2021-06-15

Completion Date

2026-06

Last Updated

2025-06-17

Healthy Volunteers

No

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.

Locations (1)

Montreal Children's hospital, Mcgill University Health Centre

Montreal, Quebec, Canada