Prematurity; Extreme Clinical Trial
Official title:
Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants: A Prospective Cross-sectional Study
NCT number | NCT04114435 |
Other study ID # | 2020-5893 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 12, 2019 |
Est. completion date | December 2025 |
Pulmonary vascular disease and cardiac performance in extreme preterm infants: A prospective cross-sectional study
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2025 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Days to 5 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Canada | Mcgill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heart function by echocardiography | STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance | 7-10 days of chronological age | |
Primary | Heart function by echocardiography | STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance | 35-37 weeks post-menstrual age | |
Primary | Heart function by echocardiography | STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance | 39-44 weeks PMA | |
Primary | Heart function by echocardiography | STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance | 4 months PMA | |
Primary | Heart function by echocardiography | STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance | 9 months PMA | |
Primary | Heart function by echocardiography | STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance | 36 months PMA | |
Primary | Heart function by echocardiography | STE allows for calculation of strain (absolute deformation) of segmental areas of the heart to provide insight on cardiac performance | 5 years chronological | |
Secondary | 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 | 7-10 days of chronological age | |
Secondary | 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 | 35-37 weeks post-menstrual age | |
Secondary | 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 | 39-44 weeks PMA | |
Secondary | 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 | 4 months PMA | |
Secondary | 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 | 9 months PMA | |
Secondary | 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 | 36 months PMA | |
Secondary | 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 | 5 years chronological |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03641209 -
Extremely Low Gestatonal Age Infants' Paracetamol Study
|
Phase 1/Phase 2 | |
Completed |
NCT04639583 -
Use of NIRS in Preterm Population Born at Altitude
|
N/A | |
Recruiting |
NCT04294368 -
Targeted Fortification of Donor Breast Milk in Preterm Infants
|
N/A | |
Completed |
NCT03504215 -
Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.
|
N/A | |
Recruiting |
NCT05615311 -
Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
|
Phase 1/Phase 2 | |
Recruiting |
NCT04735315 -
Assessment of Renal Function in Adults Born Preterm: The HAPI-Kidney Study
|
||
Completed |
NCT05684419 -
Preterm Infants Born to Homeless Mothers.
|
||
Recruiting |
NCT04270240 -
A NEW SCORING SYSTEM FOR PREDICTION OF PDA
|
||
Completed |
NCT04535375 -
Sonographic QUantification of Venous Circulation In the Preterm Brain
|
N/A | |
Recruiting |
NCT05280340 -
Anakinra for Preterm Infants Pilot
|
Phase 1/Phase 2 | |
Recruiting |
NCT05827250 -
Vibroacoustic Study of Lung Development in Newborn Infants
|
||
Recruiting |
NCT05824377 -
To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.
|
N/A | |
Completed |
NCT03635944 -
Nutritional Care and Head Growth in Preterm Infants
|
||
Completed |
NCT03261609 -
Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.
|
||
Active, not recruiting |
NCT04325308 -
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
|
N/A | |
Active, not recruiting |
NCT04545866 -
The Budesonide in Babies (BiB) Trial
|
Phase 3 |