Clinical trial NCT05698836: Cardiovascular Health Assessment of Preterm- and TERm-born Children
Official title: Cardiovascular Health Assessment of Preterm- and TERm-born Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Premature Birth
Keywords: cardiac function
preterm
children
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 3--12 years old born preterm (less than 37 weeks gestation) or term (37--42 weeks gestation) delivered at or admitted to the Oxford University Hospitals NHS Foundation Trust who took part in the EPOCH study. Recruitment also includes both siblings and friends of those who took part in the original EPOCH study.

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.

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

Primary outcomes:
measure: Cardiac left ventricular mass
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary outcomes:
measure: Cardiac right ventricular mass
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Cardiac left ventricular end-diastolic volume
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Cardiac right ventricular end-diastolic volume
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Cardiac left ventricular systolic function
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Cardiac right ventricular systolic function
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Cardiac left ventricular diastolic function
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Cardiac right ventricular diastolic function
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Morphology of the left ventricles
timeFrame: 6-9 years of age
measure: Morphology of the right ventricles
timeFrame: 6-9 years of age
measure: Cardiac flow dynamics of the left ventricle
timeFrame: 6-9 years of age
measure: Systolic blood pressure measurement
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Diastolic blood pressure measurement
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Mean arterial pressure
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Retinal arteriolar structure
timeFrame: 6-9 years of age
measure: Retinal venular structure
timeFrame: 6-9 years of age
measure: Retinal arteriolar-to-venular diameter ratio (AVR)
timeFrame: 6-9 years of age
measure: Lung function
timeFrame: 6-9 years of age
measure: Objective measure of physical activity
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Body weight
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Body height
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Body mass index
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Mid-arm circumference
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
measure: Waist-to-hip ratio
timeFrame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Other outcomes:
measure: Tube formation capacity in endothelial colony forming cells (ECFCs)
timeFrame: 6-9 years of age
measure: Endothelial colony forming cells (ECFC) branches formed
timeFrame: 6-9 years of age
measure: Endothelial colony forming cells (ECFC) colony formation
timeFrame: 6-9 years of age
measure: Endothelial colony forming cells (ECFC) proliferation rate
timeFrame: 6-9 years of age
measure: Subcortical brain volume of hippocampus
timeFrame: 6-9 years of age
measure: Subcortical brain volume of thalamus
timeFrame: 6-9 years of age
measure: White matter hyperintensities count
timeFrame: 6-9 years of age
measure: White matter hyperintensities volume
timeFrame: 6-9 years of age
measure: Cerebral vessel lumen diameter
timeFrame: 6-9 years of age
measure: Cerebral vessel density
timeFrame: 6-9 years of age
measure: Cerebral vessel tortuosity
timeFrame: 6-9 years of age
measure: Whole brain grey matter perfusion or cerebral blood flow (CBF)
timeFrame: 6-9 years of age
measure: Arterial cerebral blood volume fraction
timeFrame: 6-9 years of age
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: University of Oxford
name: Adam Lewandowski, DPhil
role: PRINCIPAL_INVESTIGATOR
References: