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
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|
|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|
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.
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.
- 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
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
|Eksel, Limburg, Belgium, 3941|
|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|