Prematurity; ExtremeNCT04114435
Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants
An observational study of Prematurity; Extreme, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study Read more about this study
- Who is it for?
- Ages 7 days to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Prematurity; Extreme
- What is being tested?
- Echocardiography
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 12 Oct 2019to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 days to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Extreme premature newborns (<29 weeks)
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mcgill University Health Centre
Montreal, Quebec, H4A 3J1
Gabriel Altit, MD, 514-412-4452, gabriel.altit@mail.mcgill.ca
About this study
Official title: 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
Read the 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.
- Conditions
- Prematurity; Extreme
- Being tested
- Echocardiography
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyOther
Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Echocardiography | |
| Infant profile ( between 4 months and 9 months) | * Echocardiography
* Ages \& stages questionnaires CAT/CLAMS assessment Receives: Other: Echocardiography | |
| 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 Receives: Other: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart function by echocardiography
STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years chronological
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 5 years chronological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start12 Oct 2019
- Primary completion30 Nov 2023
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Altit, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114435
- Sponsor's protocol ID
- 2020-5893
- Status last verified
- Jun 2025
- First submitted
- 1 Oct 2019
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants: A Prospective Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04114435
- Acronym / sponsor ID
- 2020-5893
- Conditions
- Prematurity; Extreme
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 12 Oct 2019 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neonatal profile | – | Other: EchocardiographyEchocardiography 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) | – | Other: Echocardiography* Echocardiography * Ages \& stages questionnaires CAT/CLAMS assessment |
| Pediatric profile (36 months and 5 years) | – | Other: Echocardiography* Echocardiography * Ages \& stages questionnaires CAT/CLAMS assessment * Results from 18 months PMA Bayley will be retrieved Figure 1: Premature population - Groups Recruited simultaneously |
Who may qualify
- Ages
- 7 days to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Extreme premature newborns (<29 weeks)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyDiagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures | Other | Infant profile ( between 4 months and 9 months), Neonatal profile, Pediatric profile (36 months and 5 years) |
Primary outcome
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
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
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
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
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
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
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
7 secondary outcomes
Neuro-developmental profile
Time frame: 7-10 days of chronological age
Neuro-developmental profile
Time frame: 35-37 weeks post-menstrual age
Neuro-developmental profile
Time frame: 39-44 weeks PMA
Neuro-developmental profile
Time frame: 4 months PMA
Neuro-developmental profile
Time frame: 9 months PMA
Neuro-developmental profile
Time frame: 36 months PMA
Neuro-developmental profile
Time frame: 5 years chronological
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity; Extreme, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart function by echocardiography (time frame: 7-10 days of chronological age). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.