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NCT Number: NCT05698836

Cardiovascular Health Assessment of Preterm- and TERm-born Children

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Oxford

Oxford, OX3 9DU, United Kingdom

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Cardiac right ventricular mass

    Time frame: 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)

  2. Cardiac left ventricular end-diastolic volume

    Time frame: 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)

  3. Cardiac right ventricular end-diastolic volume

    Time frame: 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)

  4. Cardiac left ventricular systolic function

    Time frame: 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 %)

  5. Cardiac right ventricular systolic function

    Time frame: 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)

  6. Cardiac left ventricular diastolic function

    Time frame: 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)

  7. Cardiac right ventricular diastolic function

    Time frame: 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

  8. Morphology of the left ventricles

    Time frame: 6-9 years of age

    MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis

  9. Morphology of the right ventricles

    Time frame: 6-9 years of age

    MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis

  10. Cardiac flow dynamics of the left ventricle

    Time frame: 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)

  11. Systolic blood pressure measurement

    Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age

    Resting brachial blood pressure measurement (in mmHg)

  12. Diastolic blood pressure measurement

    Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age

    Resting brachial blood pressure measurement (in mmHg)

  13. Mean arterial pressure

    Time frame: 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)

  14. Retinal arteriolar structure

    Time frame: 6-9 years of age

    Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging

  15. Retinal venular structure

    Time frame: 6-9 years of age

    Central retinal venular equivalent (CRVE in μm) measured using retinal imaging

  16. Retinal arteriolar-to-venular diameter ratio (AVR)

    Time frame: 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

  17. Lung function

    Time frame: 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

  18. Objective measure of physical activity

    Time frame: 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

  19. Body weight

    Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age

    Body weight measured in kg

  20. Body height

    Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age

    Body weight measured in m

  21. Body mass index

    Time frame: 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)

  22. Mid-arm circumference

    Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age

    Mid-arm circumference measured in cm

  23. Waist-to-hip ratio

    Time frame: 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)

Other outcomes

  1. Tube formation capacity in endothelial colony forming cells (ECFCs)

    Time frame: 6-9 years of age

    The number of closed tubes formed/1.5x10^4 cells

  2. Endothelial colony forming cells (ECFC) branches formed

    Time frame: 6-9 years of age

    The number of branches formed/1.5x10^4 cells

  3. Endothelial colony forming cells (ECFC) colony formation

    Time frame: 6-9 years of age

    Days for ECFC colony formation, measured in days

  4. Endothelial colony forming cells (ECFC) proliferation rate

    Time frame: 6-9 years of age

    ECFC proliferation rate, measured as a percentage

  5. Subcortical brain volume of hippocampus

    Time frame: 6-9 years of age

    Subcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI

  6. Subcortical brain volume of thalamus

    Time frame: 6-9 years of age

    Subcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI

  7. White matter hyperintensities count

    Time frame: 6-9 years of age

    The number of white matter hyperintensities on T2-weighted sequence of brain MRI

  8. White matter hyperintensities volume

    Time frame: 6-9 years of age

    Total volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI

  9. Cerebral vessel lumen diameter

    Time frame: 6-9 years of age

    Cerebral vessel lumen diameter (in μm) assessed on the time-of-flight sequence of brain MRI

  10. Cerebral vessel density

    Time frame: 6-9 years of age

    Cerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI

  11. Cerebral vessel tortuosity

    Time frame: 6-9 years of age

    The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI

  12. Whole brain grey matter perfusion or cerebral blood flow (CBF)

    Time frame: 6-9 years of age

    Whole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain MRI

  13. Arterial cerebral blood volume fraction

    Time frame: 6-9 years of age

    Arterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Acronym: CHAPTER

Important dates

Study start
2019
Primary completion
2023
Study completion
2036
First posted
Jan 26, 2023
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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