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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04114435
Enrollment
150
Registered
2019-10-03
Start date
2019-10-12
Completion date
2025-12-31
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prematurity; Extreme

Brief summary

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

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.

Interventions

OTHEREchocardiography

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

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
7 Days to 5 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Heart function by echocardiography7-10 days of chronological ageSTE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

Secondary

MeasureTime frameDescription
Neuro-developmental profile7-10 days of chronological ageNeuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026