Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia

NCT04114578 | Recruiting

• 1 other identifier: 2020-4892
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Congenital Diaphragmatic Hernia

Outcome Measures

Primary Outcomes (6)

• Assessment of cardiac function

  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %

  Within 24 hours of life

• Assessment of cardiac function

  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %

  Between day 3 to 5 of life

• Assessment of cardiac function

  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %

  Between 2 to 3 weeks of life

• Assessment of cardiac function

  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %

  age of 4 and/or 9 months

• Assessment of cardiac function

  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain)by %

  3, 5 and/or 8 years

• Assessment of cardiac function

  Our primary outcome is cardiac function assessed by STE using peak longitudinal strain) by %

  11, 14 and/or 17 years

Secondary Outcomes (6)

• Prevalence of pulmonary hypertension

  Within 24 hours of life

• Prevalence of pulmonary hypertension

  Between day 3 to 5 of life

• Prevalence of pulmonary hypertension

  Between 2 to 3 weeks of life

• Prevalence of pulmonary hypertension

  age of 4 and/or 9 months

• Prevalence of pulmonary hypertension

  3, 5 and/or 8 years

Study Arms (4)

Neonatal profile

ECHO in first 24 hours of life - ideally ECHO at Day 3-5 of life ECHO at 2-3 weeks of life or before discharge (whichever comes first) Data collected at each echocardiography: blood pressure at beginning of ECHO, pre and post-ductal saturation, respiratory support, use of inotropes and dosages, use of iNO and dosage and last blood gas

Other: Echocardiography

Infant profile ( 4 month and/or 9 month)

Echocardiography Age and stage questionnaires CAT/CLAMS assessment

Other: Echocardiography

Pediatric profile 3, 5 and/or 8years

Echocardiography Age and stage questionnaires CAT/CLAMS assessment Results from 18 months PMA Bailey will be retrieved

Other: Echocardiography

Pre-adolescent/adolescent profile 11,14 and/or 17 years

Echocardiography Pediatric Quality of Life inventory survey

Other: Echocardiography

Interventions

Echocardiography OTHER

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.

Infant profile ( 4 month and/or 9 month); Neonatal profile; Pediatric profile 3, 5 and/or 8years; Pre-adolescent/adolescent profile 11,14 and/or 17 years

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The control groups will be recruited in the normal nursery, in the NICU (term infants with antenatal suspicion of coarctation, which is ruled-out postnatally) or in clinics with conditions non-related to lungs or heart (such as: Inguinal hernia, Dermatology, Orthopedic and Benign Chest Pain clinics), as described in our previous published studies .

You may qualify if:

• CDH patients admitted to the MCH-NICU
• CDH followed at the MCH CDH clinic

You may not qualify if:

• Prematurity (\< 36 weeks)
• Diagnosis at \> 7 days of life
• Bilateral CDH
• Congenital cardiac defect (excluding a patent ductus arteriosus (PDA), atrial septal defect (ASD) or ventricular septal defect (VSD)) and/or other major anomaly/genetic syndrome.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Mcgill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 3, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)