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Prematurity as Predictor of Children's Cardiovascular-renal Health (PREMATCH)

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ClinicalTrials.gov Identifier: NCT02147457
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

Extreme preterm birth interferes with the development of the cardiovascular system. Both macro- as well as microvasculature undergoes extensive, organ specific maturation. Under normal fetal conditions, microvascular growth drives renal development and continues until 34-36 weeks of gestational age, while retinal vascular growth continues until term age. Studies show that there is association between low birth weight and cardiovascular dysfunction. According to the Barker hypothesis, this is due to nutritional shortage. In extreme preterm birth cases, this growth restriction is observed in neonatal life.

In adult life, this suboptimal growth is associated with impaired renal and (micro)vascular function, hypertension, glucose intolerance and cardiovascular disease. According to the Brenner hypothesis, disrupted renal development results in hyperfiltration and hypertension, a process that subsequently promotes itself and leads to renal impairment. We will investigate macro- and microvasculature in different organs, including eye, kidney, heart and sublingual mucosa in former preterm infants, now aged 8-13 years old and age-matched controls.

The expectation is that the results of this project will identify risk factors for cardiovascular-renal disease in the adult life of former preterm infants compared to the controls, while further analysis on mediators in neonatal life of this cardiovascular-renal outcome may provide new information on perinatal risk factors.


Condition or disease
Endothelial Dysfunction Sublingual Capillary Glycocalyx and Density Visual Disturbances and Blindness Ventricular Dysfunction, Left Renal Impairment

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Prematurity as Predictor of Children's Cardiovascular-renal Health (PREMATCH)
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Group/Cohort
ELBW (CASES)
Extremely low birth weights, born in 2000-2005, birth weight below 1000 grams, who were initially admitted (2000-2005) at the Neonatal Intensive Care Unit, UZ Leuven Belgium and have been well characterized and documented in the postnatal period.
CONTROLS
Survivors (CASES) (n = 140) will be matched with two healthy controls. One control will be matched to sex, birth year and residential area and will be suggested by the index patient (e.g. school friend, neighbor), the second control will be age and sex matched from the area of the field.



Primary Outcome Measures :
  1. Endothelial function. [ Time Frame: Baseline measurement. Cross-sectional study. ]

    Changes in the macro- and microcirculation of the cardiovascular-renal system:

    • Endothelial function
    • Sublingual capillary glycocalyx and density
    • Retinal imaging and visual acuity
    • Left ventricular function
    • Renal anatomy and function
    • Structure and function of the carotid artery (intima-media thickness, distensibility, Young's elastic modulus), aortic pulse wave velocity and the systolic augmentation index.


Biospecimen Retention:   Samples With DNA
Urine collection Blood collection


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Ages Eligible for Study:   8 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

ELBW (birth weight below 1000 g) neonates and have been well characterized and documented in the postnatal period, survivors (n = 140) will be matched with two controls. One control will be matched to sex, birth year and residential area and will be suggested by the index patient, the second control will be age and sex matched from the area of the field center. All children considered are currently between 8 and 15 years of age.

Based on GCP guidance and national law, parents or custodians will provide informed written consent, while the child has to provide informed assent.

Criteria

Inclusion Criteria:

  • 151 cases are children who were initially admitted (2000-2005) at the Neonatal Intensive Care Unit, UZ Leuven Belgium as ELBW (birth weight below 1000 g) neonates and have been well characterized and documented in the postnatal period. Survivors (n = 140) will be matched with two controls.

Exclusion Criteria:

  • If the control child is not in good health.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147457


Locations
Belgium
Research Center
Eksel, Limburg, Belgium, 3941
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Study Director: Karel M Allegaert, PhD, MD UZ Leuven, Belgium
Study Chair: Lotte Jacobs, PhD UZ Leuven
Principal Investigator: Anke MJ Raaijmakers, MD UZ Leuven, Belgium

Publications:
Kuznetsova T, Szczesny G, Thijs L, Jozeau D, D'hooge J, Staessen JA. Assessment of peripheral vascular function with photoplethysmographic pulse amplitude. Artery Research. 2011;5(2):58-64.
Liu Y-P, Richart T, Jin Y, Struijker-Boudierc HA, Staessen JA. Retinal arteriolar and venular phenotypes in a Flemish population: Reproducibility and correlates. Artery Research. 2011;5(2):72-9.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02147457     History of Changes
Other Study ID Numbers: PREMATCH
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: November 2015

Keywords provided by Universitaire Ziekenhuizen Leuven:
Prematurity
Extremely low birth weight
Phenotyping

Additional relevant MeSH terms:
Renal Insufficiency
Premature Birth
Ventricular Dysfunction
Blindness
Ventricular Dysfunction, Left
Kidney Diseases
Urologic Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Heart Diseases
Cardiovascular Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms