NCT01487824

Brief Summary

The purpose of this study is to investigate whether early life exposures such as premature birth or exposure to preeclampsia before you are born results in long-term alterations in the cardiovascular system that increase risk of cardiovascular disease development.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 8, 2019

Status Verified

June 1, 2012

Enrollment Period

8.4 years

First QC Date

December 5, 2011

Last Update Submit

January 7, 2019

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

  • Cardiac structure

    Left ventricular mass

    Young adulthood

Secondary Outcomes (4)

  • Cardiac function

    Young adulthood

  • Arterial stiffness

    Young adulthood

  • Microvascular structure

    Young adulthood

  • Cardiac structure

    Young Adulthood

Study Arms (2)

Preterm-born Young Adults

Term-born Young Adults

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Preterm-born Cohort: A cohort of preterm-born young adults who were enrolled, at birth, from five centres in England between 1982 and 1985 into a randomised trial of milk feeding regimes to study the influence of early diet on later cognitive function and cardiovascular disease. Term-born Cohort: A cohort of controls born at term with normal birthweight now aged between 20 and 40 years to provide age stratified normal ranges for the outcome measures.

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • Preterm-born Cohort: Born premature (\<37 weeks completed gestation), originally recruited as part of a randomised feeding trial at birth from one of five United Kingdom centres between 1982 and 1985.
  • Term-born Cohort: Born at term (\>37 weeks completed gestation) with normal birth weight for gestational age.
  • Able (in the Investigator's opinion) and willing to comply with all study requirements.

You may not qualify if:

  • The participant may not enter the study if ANY of the following apply:
  • Unwilling or unable to give informed consent for participation in the study.
  • Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study.
  • Contraindication to Cardiovascular Magnetic Resonance Imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Clinical Research Facility, Dept of Cardiovascular Medicine, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (2)

  • Lewandowski AJ, Lamata P, Francis JM, Piechnik SK, Ferreira VM, Boardman H, Neubauer S, Singhal A, Leeson P, Lucas A. Breast Milk Consumption in Preterm Neonates and Cardiac Shape in Adulthood. Pediatrics. 2016 Jul;138(1):e20160050. doi: 10.1542/peds.2016-0050. Epub 2016 Jun 14.

    PMID: 27302980DERIVED

  • Lewandowski AJ, Augustine D, Lamata P, Davis EF, Lazdam M, Francis J, McCormick K, Wilkinson AR, Singhal A, Lucas A, Smith NP, Neubauer S, Leeson P. Preterm heart in adult life: cardiovascular magnetic resonance reveals distinct differences in left ventricular mass, geometry, and function. Circulation. 2013 Jan 15;127(2):197-206. doi: 10.1161/CIRCULATIONAHA.112.126920. Epub 2012 Dec 5.

    PMID: 23224059DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma, immortalised cell lines

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Paul Leeson, PhD, MRCP

    Oxford Cardiovascular Clinical Research Facility, Department of Cardiovascular Medicine, University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 7, 2011

Study Start

May 1, 2007

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

January 8, 2019

Record last verified: 2012-06

Locations

GB(1)