Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia

Condition(s) studied

Investigational drug(s) / intervention(s)

Echocardiography: Echocardiography has become routinely used in the diagnosis, management, and follow-up of patients with any suspected or known heart diseases. It is one of the most widely used diagnostic tests in cardiology. It can provide a wealth of helpful information, including the size and shape of the heart (internal chamber size quantification), pumping capacity, and the location and extent of any tissue damage. An echocardiogram can also give physicians other estimates of heart function, such as a calculation of the cardiac output, ejection fraction, and diastolic function (how well the heart relaxes). The acquisition usually takes about 30 minutes.

Study summary

CDH is associated with lung hypoplasia, pulmonary hypertension, and left ventricular hypoplasia.

Use of new STE techniques (heart ultrasound) showed that CDH newborns have decreased LV size and function, potentially explaining the non-response to iNO, and that these cardiac findings were associated with poor outcomes. Our hypothesis: CDH newborns persist to have some degree of LV hypoplasia in the pediatric and adolescent life and pulmonary pressures remain increased during growth. Patients with decreased cardiac performance by STE and/or with PH have higher concomitant neonatal or pediatric morbidities and altered neurodevelopmental profile

Eligibility

Primary outcome measure(s)

• Assessment of cardiac function — Within 24 hours of life
  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %
• Assessment of cardiac function — Between day 3 to 5 of life
  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %
• Assessment of cardiac function — Between 2 to 3 weeks of life
  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %
• Assessment of cardiac function — age of 4 and/or 9 months
  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %
• Assessment of cardiac function — 3, 5 and/or 8 years
  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %
• Assessment of cardiac function — 11, 14 and/or 17 years
  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain) by %

Trial sites (1)

More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada