Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04114435

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Prematurity; Extreme Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

7 day–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mcgill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location status: Recruiting

Location contact

Gabriel Altit, MD

CONTACT

[email protected]

514-412-4452

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

echocardiography

Other

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

Primary outcomes

  1. Heart function by echocardiography

    Time frame: 7-10 days of chronological age

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

  2. Heart function by echocardiography

    Time frame: 35-37 weeks post-menstrual age

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

  3. Heart function by echocardiography

    Time frame: 39-44 weeks PMA

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

  4. Heart function by echocardiography

    Time frame: 4 months PMA

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

  5. Heart function by echocardiography

    Time frame: 9 months PMA

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

  6. Heart function by echocardiography

    Time frame: 36 months PMA

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

  7. Heart function by echocardiography

    Time frame: 5 years chronological

    STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance

Secondary outcomes

  1. Neuro-developmental profile

    Time frame: 7-10 days of chronological age

    Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

  2. Neuro-developmental profile

    Time frame: 35-37 weeks post-menstrual age

    Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

  3. Neuro-developmental profile

    Time frame: 39-44 weeks PMA

    Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

  4. Neuro-developmental profile

    Time frame: 4 months PMA

    Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

  5. Neuro-developmental profile

    Time frame: 9 months PMA

    Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

  6. Neuro-developmental profile

    Time frame: 36 months PMA

    Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

  7. Neuro-developmental profile

    Time frame: 5 years chronological

    Neuro-developmental profile of these patients at individual time points and put this profile in context of their cardiac performance by echocardiography

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Oct 3, 2019
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.