Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

Prematurity; Extreme Clinical Trial

Official title:

Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants: A Prospective Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04114435
• Other study ID #: 2020-5893
• Status: Recruiting
• Start date: October 12, 2019
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study

Description:

The principal investigator hypothesize that premature newborns have disturbed cardiac performance and increased pulmonary pressures during neonatal life and at different pediatric ages. The principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes. The principal investigator also hypothesize that premature newborns with poor cardiac performance and/or pulmonary hypertension have higher morbidities and poorer neuro-developmental outcomes and that novel echocardiography techniques will detect anomalies not uncovered by conventional imaging, and that early echocardiography may identify those with later pulmonary hypertension.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Days to 5 Years

Eligibility

Inclusion Criteria:

• Infants born at <29 weeks' gestational age admitted to the NICU
• All infants born at <29 weeks' gestational age followed at MCH clinic after an admission in the NICU for prematurity <29 weeks

Exclusion Criteria:

• Congenital heart disease (except an atrial (ASD) or ventricular septal defect (VSD), or a patent ductus arteriosus (PDA))
• Congenital severe lung or airway malformation (choanal atresia, trachea-esophageal fistula or congenital pulmonary airway malformation)
• Genetic disorder (Trisomy 21).

Related Conditions & MeSH terms

• Prematurity; Extreme
• Vascular Diseases

Intervention

Other:
• Echocardiography
Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures

Locations

Country	Name	City	State
Canada	Mcgill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart function by echocardiography	STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance	7-10 days of chronological age
Primary	Heart function by echocardiography	STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance	35-37 weeks post-menstrual age
Primary	Heart function by echocardiography	STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance	39-44 weeks PMA
Primary	Heart function by echocardiography	STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance	4 months PMA
Primary	Heart function by echocardiography	STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance	9 months PMA
Primary	Heart function by echocardiography	STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance	36 months PMA
Primary	Heart function by echocardiography	STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance	5 years chronological
Secondary	Neuro-developmental profile	Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography	7-10 days of chronological age
Secondary	Neuro-developmental profile	Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography	35-37 weeks post-menstrual age
Secondary	Neuro-developmental profile	Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography	39-44 weeks PMA
Secondary	Neuro-developmental profile	Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography	4 months PMA
Secondary	Neuro-developmental profile	Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography	9 months PMA
Secondary	Neuro-developmental profile	Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography	36 months PMA
Secondary	Neuro-developmental profile	Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography	5 years chronological