Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

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

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

Study Overview

• Status: Recruiting
• Conditions: Prematurity; Extreme
• Intervention / Treatment: Other: Echocardiography

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre
      • Contact: Gabriel Altit, MD; Phone Number: 514-412-4452; Email: gabriel.altit@mail.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 5 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Extreme premature newborns (<29 weeks)

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neonatal profile; Echocardiography at: 7 to 10 days of chronological age; 35 to 37 weeks post-menstrual age (PMA = corrected age);; 39 to 44 weeks PMA; Term equivalent	Other: Echocardiography; Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures
Infant profile ( between 4 months and 9 months); Echocardiography; Ages & stages questionnaires CAT/CLAMS assessment	Other: Echocardiography; Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures
Pediatric profile (36 months and 5 years); Echocardiography; Ages & stages questionnaires CAT/CLAMS assessment; Results from 18 months PMA Bayley will be retrieved Figure 1: Premature population - Groups Recruited simultaneously	Other: Echocardiography; Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2019
• Primary Completion (Actual): November 30, 2023
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: 2020-5893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No