Pulmonary Vascular Disease and Cardiac Performance in Extreme Preterm Infants

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

Detailed Description
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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.

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

Conditions
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Prematurity; Extreme

Intervention / Treatment
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* Other: Echocardiography


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neonatal profile<br>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 | Other: Echocardiography<br>* Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures<br>|
| Infant profile ( between 4 months and 9 months)<br>Echocardiography Ages & stages questionnaires CAT/CLAMS assessment | Other: Echocardiography<br>* Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures<br>|
| Pediatric profile (36 months and 5 years)<br>Echocardiography Ages & stages questionnaires CAT/CLAMS assessment Results from 18 months PMA Bayley will be retrieved Figure 1: Premature population - Groups Recruited simultaneously | Other: Echocardiography<br>* Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |