Cardiovascular Health Assessment of Preterm- and TERm-born Children

NCT05698836 | Enrolling By Invitation

• 1 other identifier: 18/WM/0131
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

cardiac function; preterm; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Cardiac right ventricular mass

  3-5 years of age OR 8-12 years of age; AND 6-9 years of age

• Cardiac left ventricular end-diastolic volume

  3-5 years of age OR 8-12 years of age; AND 6-9 years of age

• Cardiac right ventricular end-diastolic volume

  3-5 years of age OR 8-12 years of age; AND 6-9 years of age

• Cardiac left ventricular systolic function

  3-5 years of age OR 8-12 years of age; AND 6-9 years of age

• Cardiac right ventricular systolic function

  3-5 years of age OR 8-12 years of age; AND 6-9 years of age

Other Outcomes (13)

• Tube formation capacity in endothelial colony forming cells (ECFCs)

  6-9 years of age

• Endothelial colony forming cells (ECFC) branches formed

  6-9 years of age

• Endothelial colony forming cells (ECFC) colony formation

  6-9 years of age

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Adam Lewandowski, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: January 26, 2023
• Study Start: March 21, 2019
• Primary Completion: May 31, 2023
• Study Completion (Estimated): June 1, 2036
• Last Updated: January 26, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)