Cardiovascular Health Assessment of Preterm- and TERm-born Children

Study Overview
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Brief Summary
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The purpose of the CHAPTER study is to help understand how complications during pregnancy, such as preterm birth, affect how childrens' hearts and blood vessels develop.

Detailed Description
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Young adults born preterm (less than 37 weeks gestation) have alterations in the structure and function of the heart, with similar changes observed in preterm infants in the first three months of life. It is unknown whether these early changes in the heart seen in the first few months of life are relevant to long-term changes in heart structure and function. Heart changes have also not been well studied in children born preterm. To investigate this, the study will follow up children from the EPOCH study and will perform two study visits for each child (n=100 preterm and n=100 term) that will use echocardiography and cardiovascular magnetic resonance. Individuals in the EPOCH study had echocardiography measures done at birth and three months postnatal age. It will therefore be possible to do longitudinal echocardiography measures from birth up to ages 12 years to determine whether postnatal heart changes in preterm infants track into childhood. Cardiovascular magnetic resonance will allow for the determination of whether these early heart changes influence heart pump function. Finally, by measuring lung function, blood vessel structure and function, and blood pressure, it will be possible to determine how heart changes relate to other components of the cardiovascular system. This data will be used to confirm the relevance of early heart remodelling in preterm-born offspring over time and provide more comprehensive heart phenotyping for preterm-born children. Together, this information can be used to design future intervention strategies in preterm-born individuals to reduce cardiovascular risk in this growing subgroup of the population.

Official Title
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Cardiovascular Health Assessment of Preterm- and TERm-born Children

Conditions
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Premature Birth

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant's parent or legal guardian gives consent and the participant, where age-appropriate, gives assent for participation in the study. Participant is male or female, aged 3-9 years at enrolment. Participant previously took part in the EPOCH study, or the participant's friend or sibling took part. Exclusion Criteria: Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status For exclusion of MRI component only: Contraindication to MRI Unsuitable for MRI based on the responses to the MRI screening form

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac left ventricular mass | Echocardiography assessment of left ventricular mass indexed to body surface area (in g and g/m^2) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac right ventricular mass | Echocardiography assessment of right ventricular mass indexed to body surface area (in g and g/m^2) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Cardiac left ventricular end-diastolic volume | Echocardiography assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Cardiac right ventricular end-diastolic volume | Echocardiography assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Cardiac left ventricular systolic function | Echocardiography assessment of left ventricular systolic function: left ventricular ejection fraction (in %) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Cardiac right ventricular systolic function | Echocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (in cm) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Cardiac left ventricular diastolic function | Echocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Cardiac right ventricular diastolic function | Echocardiography assessment of left ventricular (LV) diastolic function: LV Doppler early/late diastolic mitral inflow | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Morphology of the left ventricles | MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis | 6-9 years of age | 
| Morphology of the right ventricles | MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis | 6-9 years of age | 
| Cardiac flow dynamics of the left ventricle | MRI assessment of direct flow, delayed ejection flow, retained inflow, residual volume kinetic energy flow components at end diastole (measured at end diastole in mJ and overall % contribution) | 6-9 years of age | 
| Systolic blood pressure measurement | Resting brachial blood pressure measurement (in mmHg) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Diastolic blood pressure measurement | Resting brachial blood pressure measurement (in mmHg) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Mean arterial pressure | The average arterial pressure from resting brachial blood pressure measurement (in mmHg) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Retinal arteriolar structure | Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging | 6-9 years of age | 
| Retinal venular structure | Central retinal venular equivalent (CRVE in μm) measured using retinal imaging | 6-9 years of age | 
| Retinal arteriolar-to-venular diameter ratio (AVR) | The ratio of average retinal arteriolar diameter (CRAE in μm) and average retinal venous diameter (CRVE in μm) measured using retinal imaging | 6-9 years of age | 
| Lung function | The forced expiratory volume in one second (FEV1 in L), forced vital capacity (FVC in L), and the ratio of FEV1 to FVC (FEV1/FVC) measured using spirometry | 6-9 years of age | 
| Objective measure of physical activity | The amount of moderate to vigorous physical activity (in h/week) and vigorous physical activity (in h/week) measured using wrist worn accelerometer | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Body weight | Body weight measured in kg | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Body height | Body weight measured in m | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Body mass index | Body weight divided by the square of height (in kg/m2) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Mid-arm circumference | Mid-arm circumference measured in cm | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 
| Waist-to-hip ratio | The ratio of waist circumference (in cm) to hip circumference (in cm) | 3-5 years of age OR 8-12 years of age; AND 6-9 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac function, preterm, children