Clinical trial NCT04644094: Postnatal Steroids Effects on Cardiac Function in Extremely Preterm
Official title: "Surveillance of Postnatal Steroids Effects on Cardiac Function in Extremely Preterm Infants With Evolving BPD: the SPEC Study."
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Ventricular Hypertrophy
Keywords: Lung ultrasound
Echocardiography
Heart rate variability
Left ventricular hypertrophy
Ductus arteriosus
Dexamethasone
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Extreme premature babies (\< 29 weeks of gestational age at birth) undergoing first treatment with dexamethasone for significant lung disease at the neonatal intensive care.

Brief 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

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.

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

Primary outcomes:
measure: Left ventricular hypertrophy (LVH) measures by M-mode (Z-Scores)
timeFrame: At the time of echocardiography
measure: Lung water content
timeFrame: At the time of echocardiography
Secondary outcomes:
measure: Left ventricular (LV) output
timeFrame: At the time of echocardiography
measure: LV and RV function by strain
timeFrame: At the time of echocardiography
measure: LV ejection fraction
timeFrame: At the time of echocardiography
measure: Ductal size
timeFrame: At the time of echocardiography
measure: Doppler flow velocities
timeFrame: At the time of echocardiography
measure: Measures of PDA significance
timeFrame: At the time of echocardiography
measure: LV mass by STE
timeFrame: At the time of echocardiography
measure: RV function by TAPSE
timeFrame: At the time of echocardiography
measure: Strain and 3D values
timeFrame: At the time of echocardiography
measure: Heart rate variability
timeFrame: At the time of echocardiography
measure: Growth trajectory
timeFrame: At the time of the last echocardiography
measure: Cortisol levels
timeFrame: At the study completion (12 months)
measure: BPD
timeFrame: At the study completion (12 months)
measure: Mortality
timeFrame: At the study completion (12 months)
measure: Responders and non responders to Dexamethasone
timeFrame: At the study completion (12 months)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Children's hospital, Mcgill University Health Centre
state: Quebec
Study officials:
affiliation: Montreal Children's hospital, MUHC
name: Gabriel Altit, MD
role: PRINCIPAL_INVESTIGATOR
References: