Cardiovascular Health Assessment of Preterm- and TERm-born Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Birth
- Sponsor
- University of Oxford
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Cardiac left ventricular mass
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cardiac left ventricular mass
Time Frame: 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 Outcomes
- Cardiac right ventricular systolic function(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Cardiac left ventricular diastolic function(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Cardiac right ventricular diastolic function(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Morphology of the left ventricles(6-9 years of age)
- Morphology of the right ventricles(6-9 years of age)
- Cardiac flow dynamics of the left ventricle(6-9 years of age)
- Systolic blood pressure measurement(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Diastolic blood pressure measurement(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Cardiac right ventricular mass(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Lung function(6-9 years of age)
- Cardiac left ventricular end-diastolic volume(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Cardiac right ventricular end-diastolic volume(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Cardiac left ventricular systolic function(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Mean arterial pressure(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Retinal arteriolar structure(6-9 years of age)
- Retinal venular structure(6-9 years of age)
- Retinal arteriolar-to-venular diameter ratio (AVR)(6-9 years of age)
- Objective measure of physical activity(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Body weight(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Body height(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Body mass index(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Mid-arm circumference(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)
- Waist-to-hip ratio(3-5 years of age OR 8-12 years of age; AND 6-9 years of age)