Cardiovascular Health Assessment of Preterm- and TERm-born Children
- Conditions
- Premature Birth
- Registration Number
- NCT05698836
- Lead Sponsor
- University of Oxford
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac left ventricular mass 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of left ventricular mass indexed to body surface area (in g and g/m\^2)
- Secondary Outcome Measures
Name Time Method Cardiac right ventricular systolic function 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (in cm)
Cardiac left ventricular diastolic function 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)
Cardiac right ventricular diastolic function 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of left ventricular (LV) diastolic function: LV Doppler early/late diastolic mitral inflow
Morphology of the left ventricles 6-9 years of age MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis
Morphology of the right ventricles 6-9 years of age MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis
Cardiac flow dynamics of the left ventricle 6-9 years of age 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)
Systolic blood pressure measurement 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Resting brachial blood pressure measurement (in mmHg)
Diastolic blood pressure measurement 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Resting brachial blood pressure measurement (in mmHg)
Cardiac right ventricular mass 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of right ventricular mass indexed to body surface area (in g and g/m\^2)
Lung function 6-9 years of age 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
Cardiac left ventricular end-diastolic volume 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\^2)
Cardiac right ventricular end-diastolic volume 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\^2)
Cardiac left ventricular systolic function 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Echocardiography assessment of left ventricular systolic function: left ventricular ejection fraction (in %)
Mean arterial pressure 3-5 years of age OR 8-12 years of age; AND 6-9 years of age The average arterial pressure from resting brachial blood pressure measurement (in mmHg)
Retinal arteriolar structure 6-9 years of age Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging
Retinal venular structure 6-9 years of age Central retinal venular equivalent (CRVE in μm) measured using retinal imaging
Retinal arteriolar-to-venular diameter ratio (AVR) 6-9 years of age The ratio of average retinal arteriolar diameter (CRAE in μm) and average retinal venous diameter (CRVE in μm) measured using retinal imaging
Objective measure of physical activity 3-5 years of age OR 8-12 years of age; AND 6-9 years of age The amount of moderate to vigorous physical activity (in h/week) and vigorous physical activity (in h/week) measured using wrist worn accelerometer
Body weight 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Body weight measured in kg
Body height 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Body weight measured in m
Body mass index 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Body weight divided by the square of height (in kg/m2)
Mid-arm circumference 3-5 years of age OR 8-12 years of age; AND 6-9 years of age Mid-arm circumference measured in cm
Waist-to-hip ratio 3-5 years of age OR 8-12 years of age; AND 6-9 years of age The ratio of waist circumference (in cm) to hip circumference (in cm)
Trial Locations
- Locations (1)
University of Oxford
🇬🇧Oxford, United Kingdom