Clinical Trials Directory

Trials / Enrolling By Invitation

Enrolling By InvitationNCT05698836

Cardiovascular Health Assessment of Preterm- and TERm-born Children

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
University of Oxford · Academic / Other
Sex
All
Age
3 Years – 9 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2019-03-21
Primary completion
2023-05-31
Completion
2036-06-01
First posted
2023-01-26
Last updated
2023-01-26

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05698836. Inclusion in this directory is not an endorsement.