The risk of Arterial Hypertension (HTA) is increased in very premature infants and hydrocortisone administered in the neonatal period could modify this risk. The main objective is to assess whether the administration of hydrocortisone in the perinatal period in children born prematurely is associated with an increase in Pulse Wave Velocity (PWV) by comparing the future of children included in the PREMILOC trial (hydrocortisone versus placebo) at the age of 7-13 years. The primary endpoint will be the carotid-femoral pulse wave velocity in m/s.
Descriptive cross-sectional study of the subjects included in the double-blind, monocentric randomized controlled trial (children included and followed up at the Robert Debré hospital in the PREMILOC trial): follow-up of these children approximately 10 years later on vascular parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
80
Completion of the physical activity and quality of life questionnaire (PedSQL adapted to the age of the child), measurement of weight and height; Measurement of VOP (Pulse wave velocity), AI (increase index) and ECG (electro cardiogram) collection at rest lying down; Stimulation test by slow breathing at 6 cycles/min for three minutes; Continuation of the measurements in a standing position for 5 minutes; Installation of blood pressure holter (MAPA) which will be kept for 24 hours and then returned by post.
Robert Debre Hospital
Paris, France
RECRUITINGVelocity of the carotid-femoral pulse wave in m/s (VOP)
Velocity of the carotid-femoral pulse wave in m/s measured by the SphygmoCor device.
Time frame: Inclusion
Index increase of VOP
Index increase measured by the SphygmoCor device
Time frame: Inclusion
Cardio-Radial Pulse Wave Velocity
Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths
Time frame: Inclusion
Sensitivity of the baroreflex
Sensitivity of the baroreflex (up and down measurement, average; standing versus lying down: Biopac device) in ms/mmHg; 3 measures: supine, standing and deep breaths
Time frame: Inclusion
High Frequence bare of the sympatho-vagal balance
in ms\^2; 3 measures: supine, standing and deep breaths
Time frame: Inclusion
High Frequence bare of the sympatho-vagal balance
in percent; 3 measures: supine, standing and deep breaths
Time frame: Inclusion
Low frequence bare of the sympatho-vagal balance
in percent; 3 measures: supine, standing and deep breaths
Time frame: Inclusion
Low frequence bare of the sympatho-vagal balance
in ms\^2; 3 measures: supine, standing and deep breaths
Time frame: Inclusion
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Time frame: Inclusion
Parameters from ambulatory blood pressure measurement (ABPM)
Parameters from ambulatory blood pressure measurement (ABPM) (Spacelabs device) 24-hour systolic and diastolic average, day, night, systolic and diastolic nocturnal dipping
Time frame: During 24 hours
Other factors associated with the risk of early hypertension: quality of life
quality of life: PedsQL quizz
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: presence of overweight
presence of overweight (yes/no)
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: etnicity
ethnicity
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: daily physical activity
daily physical activity: number of hours of physical activity per day
Time frame: Data retrieved on inclusion
Other factors associated with the risk of early hypertension: Fetal growth restriction
Fetal growth restriction during the pregnancy (yes/no)
Time frame: Data retrieved on inclusion
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