Cardiovascular Health Assessment of Preterm- and TERm-born Children

Premature Birth Clinical Trial

— CHAPTER  

Official title:

Cardiovascular Health Assessment of Preterm- and TERm-born Children

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05698836
• Other study ID #: 18/WM/0131
• Status: Enrolling by invitation
• Start date: March 21, 2019
• Est. completion date: June 1, 2036

Study information

• Verified date: October 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 1, 2036
• Est. primary completion date: May 31, 2023
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tube formation capacity in endothelial colony forming cells (ECFCs)	The number of closed tubes formed/1.5x10^4 cells	6-9 years of age
Other	Endothelial colony forming cells (ECFC) branches formed	The number of branches formed/1.5x10^4 cells	6-9 years of age
Other	Endothelial colony forming cells (ECFC) colony formation	Days for ECFC colony formation, measured in days	6-9 years of age
Other	Endothelial colony forming cells (ECFC) proliferation rate	ECFC proliferation rate, measured as a percentage	6-9 years of age
Other	Subcortical brain volume of hippocampus	Subcortical brain volume of hippocampus (in mm3) assessed on T1-weighted sequence of brain MRI	6-9 years of age
Other	Subcortical brain volume of thalamus	Subcortical brain volume of thalamus (in mm3) assessed on T1-weighted sequence of brain MRI	6-9 years of age
Other	White matter hyperintensities count	The number of white matter hyperintensities on T2-weighted sequence of brain MRI	6-9 years of age
Other	White matter hyperintensities volume	Total volume of white matter hyperintensities (in mm3) assessed on T2-weighted sequence of brain MRI	6-9 years of age
Other	Cerebral vessel lumen diameter	Cerebral vessel lumen diameter (in µm) assessed on the time-of-flight sequence of brain MRI	6-9 years of age
Other	Cerebral vessel density	Cerebral vessel density (in mm3) assessed on the time-of-flight sequence of brain MRI	6-9 years of age
Other	Cerebral vessel tortuosity	The ratio of cerebral vessel tortuosity assessed on the time-of-flight sequence of brain MRI	6-9 years of age
Other	Whole brain grey matter perfusion or cerebral blood flow (CBF)	Whole brain grey matter perfusion/CBF (in ml/100g/min) assessed on arterial spin labelling of brain MRI	6-9 years of age
Other	Arterial cerebral blood volume fraction	Arterial cerebral blood volume fraction (in %) assessed on arterial spin labelling of brain MRI	6-9 years of age
Primary	Cardiac left ventricular mass	Echocardiography assessment of left ventricular mass indexed to body surface area (in g and g/m^2)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Cardiac right ventricular mass	Echocardiography assessment of right ventricular mass indexed to body surface area (in g and g/m^2)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Cardiac left ventricular end-diastolic volume	Echocardiography assessment of cardiac left ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Cardiac right ventricular end-diastolic volume	Echocardiography assessment of cardiac right ventricular end-diastolic volume indexed to body surface area (in ml and ml/m^2)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Cardiac left ventricular systolic function	Echocardiography assessment of left ventricular systolic function: left ventricular ejection fraction (in %)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Cardiac right ventricular systolic function	Echocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (in cm)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Cardiac left ventricular diastolic function	Echocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Cardiac right ventricular diastolic function	Echocardiography assessment of left ventricular (LV) diastolic function: LV Doppler early/late diastolic mitral inflow	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Morphology of the left ventricles	MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis	6-9 years of age
Secondary	Morphology of the right ventricles	MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis	6-9 years of age
Secondary	Cardiac flow dynamics of the left ventricle	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)	6-9 years of age
Secondary	Systolic blood pressure measurement	Resting brachial blood pressure measurement (in mmHg)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Diastolic blood pressure measurement	Resting brachial blood pressure measurement (in mmHg)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Mean arterial pressure	The average arterial pressure from resting brachial blood pressure measurement (in mmHg)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Retinal arteriolar structure	Central retinal arteriolar equivalent (CRAE in µm) measured using retinal imaging	6-9 years of age
Secondary	Retinal venular structure	Central retinal venular equivalent (CRVE in µm) measured using retinal imaging	6-9 years of age
Secondary	Retinal arteriolar-to-venular diameter ratio (AVR)	The ratio of average retinal arteriolar diameter (CRAE in µm) and average retinal venous diameter (CRVE in µm) measured using retinal imaging	6-9 years of age
Secondary	Lung function	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	6-9 years of age
Secondary	Objective measure of physical activity	The amount of moderate to vigorous physical activity (in h/week) and vigorous physical activity (in h/week) measured using wrist worn accelerometer	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Body weight	Body weight measured in kg	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Body height	Body weight measured in m	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Body mass index	Body weight divided by the square of height (in kg/m2)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Mid-arm circumference	Mid-arm circumference measured in cm	3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary	Waist-to-hip ratio	The ratio of waist circumference (in cm) to hip circumference (in cm)	3-5 years of age OR 8-12 years of age; AND 6-9 years of age