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Cardiovascular Health Assessment of Preterm- and TERm-born Children

Cardiovascular Health Assessment of Preterm- and TERm-born Children

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05698836
Acronym
CHAPTER
Enrollment
200
Registered
2023-01-26
Start date
2019-03-21
Completion date
2036-06-01
Last updated
2023-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

cardiac function, preterm, children

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.

Interventions

None listed

Sponsors

University of Oxford
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 9 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac left ventricular mass3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of left ventricular mass indexed to body surface area (in g and g/m\^2)

Secondary

MeasureTime frameDescription
Cardiac left ventricular diastolic function3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)
Cardiac flow dynamics of the left ventricle6-9 years of ageMRI 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)
Body height3-5 years of age OR 8-12 years of age; AND 6-9 years of ageBody weight measured in m
Body mass index3-5 years of age OR 8-12 years of age; AND 6-9 years of ageBody weight divided by the square of height (in kg/m2)
Systolic blood pressure measurement3-5 years of age OR 8-12 years of age; AND 6-9 years of ageResting brachial blood pressure measurement (in mmHg)
Diastolic blood pressure measurement3-5 years of age OR 8-12 years of age; AND 6-9 years of ageResting brachial blood pressure measurement (in mmHg)
Mean arterial pressure3-5 years of age OR 8-12 years of age; AND 6-9 years of ageThe average arterial pressure from resting brachial blood pressure measurement (in mmHg)
Retinal arteriolar structure6-9 years of ageCentral retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging
Retinal venular structure6-9 years of ageCentral retinal venular equivalent (CRVE in μm) measured using retinal imaging
Retinal arteriolar-to-venular diameter ratio (AVR)6-9 years of ageThe ratio of average retinal arteriolar diameter (CRAE in μm) and average retinal venous diameter (CRVE in μm) measured using retinal imaging
Lung function6-9 years of ageThe 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
Objective measure of physical activity3-5 years of age OR 8-12 years of age; AND 6-9 years of ageThe amount of moderate to vigorous physical activity (in h/week) and vigorous physical activity (in h/week) measured using wrist worn accelerometer
Mid-arm circumference3-5 years of age OR 8-12 years of age; AND 6-9 years of ageMid-arm circumference measured in cm
Waist-to-hip ratio3-5 years of age OR 8-12 years of age; AND 6-9 years of ageThe ratio of waist circumference (in cm) to hip circumference (in cm)
Cardiac right ventricular mass3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of right ventricular mass indexed to body surface area (in g and g/m\^2)
Cardiac left ventricular end-diastolic volume3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\^2)
Cardiac right ventricular end-diastolic volume3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m\^2)
Cardiac left ventricular systolic function3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of left ventricular systolic function: left ventricular ejection fraction (in %)
Cardiac right ventricular systolic function3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (in cm)
Body weight3-5 years of age OR 8-12 years of age; AND 6-9 years of ageBody weight measured in kg
Cardiac right ventricular diastolic function3-5 years of age OR 8-12 years of age; AND 6-9 years of ageEchocardiography assessment of left ventricular (LV) diastolic function: LV Doppler early/late diastolic mitral inflow
Morphology of the left ventricles6-9 years of ageMRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis
Morphology of the right ventricles6-9 years of ageMRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis

Other

MeasureTime frameDescription
Endothelial colony forming cells (ECFC) colony formation6-9 years of ageDays for ECFC colony formation, measured in days
Endothelial colony forming cells (ECFC) proliferation rate6-9 years of ageECFC proliferation rate, measured as a percentage
Subcortical brain volume of hippocampus6-9 years of ageSubcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI
Subcortical brain volume of thalamus6-9 years of ageSubcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI
White matter hyperintensities count6-9 years of ageThe number of white matter hyperintensities on T2-weighted sequence of brain MRI
White matter hyperintensities volume6-9 years of ageTotal volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI
Cerebral vessel lumen diameter6-9 years of ageCerebral vessel lumen diameter (in μm) assessed on the time-of-flight sequence of brain MRI
Cerebral vessel density6-9 years of ageCerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI
Cerebral vessel tortuosity6-9 years of ageThe ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI
Whole brain grey matter perfusion or cerebral blood flow (CBF)6-9 years of ageWhole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain MRI
Arterial cerebral blood volume fraction6-9 years of ageArterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI
Endothelial colony forming cells (ECFC) branches formed6-9 years of ageThe number of branches formed/1.5x10\^4 cells
Tube formation capacity in endothelial colony forming cells (ECFCs)6-9 years of ageThe number of closed tubes formed/1.5x10\^4 cells

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026