Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

NCT ID: NCT04114435

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-12

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prematurity; Extreme

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Echocardiography

Intervention Type OTHER

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

Echocardiography

Intervention Type OTHER

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

Echocardiography

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echocardiography

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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).
Minimum Eligible Age

7 Days

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gabriel Altit

Neonatologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mcgill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Gabriel Altit, MD

Role: primary

514-412-4452

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-5893

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.