Recruiting

Observational Study

Sponsor:

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

Code:

NCT04114435

Conditions

Prematurity; Extreme

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Accepted

Interventions

Echocardiography

Study Details

Brief summary:

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

Conditions

Prematurity; Extreme

Study ID

NCT04114435

Start date

Oct 12, 2019

Status verified date

Jun, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Nov 30, 2023

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 5

Healthy Volunteers: Accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Infant profile ( between 4 months and 9 months)

  • Echocardiography
  • Ages \& stages questionnaires CAT/CLAMS assessment

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

Interventions

Echocardiography

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

Primary outcome measure

  • Heart function by echocardiography [ Time Frame: 7-10 days of chronological age ]
  • Heart function by echocardiography [ Time Frame: 35-37 weeks post-menstrual age ]
  • Heart function by echocardiography [ Time Frame: 39-44 weeks PMA ]
  • Heart function by echocardiography [ Time Frame: 4 months PMA ]
  • Heart function by echocardiography [ Time Frame: 9 months PMA ]
  • Heart function by echocardiography [ Time Frame: 36 months PMA ]
  • Heart function by echocardiography [ Time Frame: 5 years chronological ]

Central Contacts and Locations

Locations

Mcgill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Gabriel Altit, MD

514-412-4452gabriel.altit@mail.mcgill.ca

More Information

Sponsor

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

Last update posted

Jun 17, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2025-06-17.