Cardiovascular Health Assessment of Preterm- and TERm-born Children
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Premature Birth. Базовые параметры: 3 лет — 9 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Cardiac left ventricular mass [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
Вторичные конечные точки (12)
- Cardiac right ventricular mass [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Cardiac left ventricular end-diastolic volume [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Cardiac right ventricular end-diastolic volume [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Cardiac left ventricular systolic function [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Cardiac right ventricular systolic function [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Cardiac left ventricular diastolic function [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Cardiac right ventricular diastolic function [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Morphology of the left ventricles [Срок оценки: 6-9 years of age]
- Morphology of the right ventricles [Срок оценки: 6-9 years of age]
- Cardiac flow dynamics of the left ventricle [Срок оценки: 6-9 years of age]
- Systolic blood pressure measurement [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
- Diastolic blood pressure measurement [Срок оценки: 3-5 years of age OR 8-12 years of age; AND 6-9 years of age]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Великобритания · 1 центр
- University of Oxford — Oxford
Идентификаторы
NCT: NCT05698836 · 18/WM/0131