Premature BirthCHAPTERNCT05698836
Cardiovascular Health Assessment of Preterm- and TERm-born Children
An observational study of Premature Birth, run by University of Oxford at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Premature Birth
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Mar 2019to 1 Jun 2036
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Premature Birth
- Keywords
- cardiac function, preterm, children
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac left ventricular mass
Echocardiography assessment of left ventricular mass indexed to body surface area (in g and g/m^2)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Secondary outcomes (23)
Cardiac right ventricular mass
Echocardiography assessment of right ventricular mass indexed to body surface area (in g and g/m^2)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
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)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
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)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Cardiac left ventricular systolic function
Echocardiography assessment of left ventricular systolic function: left ventricular ejection fraction (in %)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Cardiac right ventricular systolic function
Echocardiography assessment of right ventricular systolic function: tricuspid annular plane systolic excursion (in cm)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Cardiac left ventricular diastolic function
Echocardiography assessment of right ventricular (RV) diastolic function: RV Doppler early/late diastolic tricuspid inflow velocity ratio (E/A)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Cardiac right ventricular diastolic function
Echocardiography assessment of left ventricular (LV) diastolic function: LV Doppler early/late diastolic mitral inflow
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Morphology of the left ventricles
MRI assessment of the left ventricles morphology using cardiac statistical atlas and principal component analysis
Measured: 6-9 years of age
Morphology of the right ventricles
MRI assessment of the right ventricles morphology using cardiac statistical atlas and principal component analysis
Measured: 6-9 years of age
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)
Measured: 6-9 years of age
Systolic blood pressure measurement
Resting brachial blood pressure measurement (in mmHg)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Diastolic blood pressure measurement
Resting brachial blood pressure measurement (in mmHg)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Mean arterial pressure
The average arterial pressure from resting brachial blood pressure measurement (in mmHg)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Retinal arteriolar structure
Central retinal arteriolar equivalent (CRAE in μm) measured using retinal imaging
Measured: 6-9 years of age
Retinal venular structure
Central retinal venular equivalent (CRVE in μm) measured using retinal imaging
Measured: 6-9 years of age
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
Measured: 6-9 years of age
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
Measured: 6-9 years of age
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
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Body weight
Body weight measured in kg
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Body height
Body weight measured in m
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Body mass index
Body weight divided by the square of height (in kg/m2)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Mid-arm circumference
Mid-arm circumference measured in cm
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Waist-to-hip ratio
The ratio of waist circumference (in cm) to hip circumference (in cm)
Measured: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start21 Mar 2019
- Primary completion31 May 2023 (estimated)
- Study completion1 Jun 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Lewandowski, DPhil, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698836
- Sponsor's protocol ID
- 18/WM/0131
- Acronym
- CHAPTER
- Status last verified
- Oct 2022
- First submitted
- 31 Oct 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sattwika PD, Suriano K, Fernandes JF, den Harink T, Aye CYL, Kenworthy Y, McCourt A, Raman B, Ashkir Z, Hess AT, Pelado JL, Viola F, Ebbers T, Carlhall CJ, Dyverfeldt P, de Vecchi A, Lapidaire W, Leeson P, Lamata P, Lewandowski AJ. Cardiac morphology and flow dynamics in children born to hypertensive pregnancies. Eur Heart J Imaging Methods Pract. 2026 Aug 20;4(3):qyag145. doi: 10.1093/ehjimp/qyag145. eCollection 2026 Aug.
PubMed 42699537
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Health Assessment of Preterm- and TERm-born Children
- ClinicalTrials.gov ID
- NCT05698836
- Acronym / sponsor ID
- CHAPTER / 18/WM/0131
- Conditions
- Premature Birth
- Keywords
- cardiac function, preterm, children
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 1 Jun 2036 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status
- Contraindication to MRI
- Unsuitable for MRI based on the responses to the MRI screening form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
23 secondary outcomes
Cardiac right ventricular mass
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
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
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
Cardiac left ventricular systolic function
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Cardiac right ventricular systolic function
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Cardiac left ventricular diastolic function
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Cardiac right ventricular diastolic function
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Morphology of the left ventricles
Time frame: 6-9 years of age
Morphology of the right ventricles
Time frame: 6-9 years of age
Cardiac flow dynamics of the left ventricle
Time frame: 6-9 years of age
Systolic blood pressure measurement
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Diastolic blood pressure measurement
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Mean arterial pressure
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Retinal arteriolar structure
Time frame: 6-9 years of age
Retinal venular structure
Time frame: 6-9 years of age
Retinal arteriolar-to-venular diameter ratio (AVR)
Time frame: 6-9 years of age
Lung function
Time frame: 6-9 years of age
Objective measure of physical activity
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Body weight
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Body height
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Body mass index
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Mid-arm circumference
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Waist-to-hip ratio
Time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Derived from this study: PubMed 42699537Sattwika PD, Suriano K, Fernandes JF, den Harink T, Aye CYL, Kenworthy Y, McCourt A, Raman B, Ashkir Z, Hess AT, Pelado JL, Viola F, Ebbers T, Carlhall CJ, Dyverfeldt P, de Vecchi A, Lapidaire W, Leeson P, Lamata P, Lewandowski AJ. Cardiac morphology and flow dynamics in children born to hypertensive pregnancies. Eur Heart J Imaging Methods Pract. 2026 Aug 20;4(3):qyag145. doi: 10.1093/ehjimp/qyag145. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Lewandowski, DPhil principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac left ventricular mass (time frame: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05698836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.