Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children (PREMILOCAP)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children

Conditions
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Infant, Premature, Diseases

Intervention / Treatment
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* Diagnostic Test: blood pressure measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Child included in the PREMILOC trial on the Robert Debré site Age from 7 to 13 years old (eve of 14 years old) Consent of the holders of parental authority and agreement of the child Exclusion Criteria: Absence of affiliation to a social security scheme Patient under state medical aid

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrocortisone<br>During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). | Diagnostic Test: blood pressure measurement<br>* 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.<br>|
| Placebo Comparator: Placebo<br>During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). | Diagnostic Test: blood pressure measurement<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Velocity 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. | Inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index increase of VOP | Index increase measured by the SphygmoCor device | Inclusion | 
| Cardio-Radial Pulse Wave Velocity | Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths | 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 | Inclusion | 
| High Frequence bare of the sympatho-vagal balance | in ms^2; 3 measures: supine, standing and deep breaths | Inclusion | 
| High Frequence bare of the sympatho-vagal balance | in percent; 3 measures: supine, standing and deep breaths | Inclusion | 
| Low frequence bare of the sympatho-vagal balance | in percent; 3 measures: supine, standing and deep breaths | Inclusion | 
| Low frequence bare of the sympatho-vagal balance | in ms^2; 3 measures: supine, standing and deep breaths | Inclusion | 
| Low Frequence/High Frequence ratio of the sympatho-vagal balance | Low Frequence/High Frequence ratio of the sympatho-vagal balance | 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 | During 24 hours | 
| Other factors associated with the risk of early hypertension: quality of life | quality of life: PedsQL quizz | Data retrieved on inclusion | 
| Other factors associated with the risk of early hypertension: presence of overweight | presence of overweight (yes/no) | Data retrieved on inclusion | 
| Other factors associated with the risk of early hypertension: etnicity | ethnicity | 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 | Data retrieved on inclusion | 
| Other factors associated with the risk of early hypertension: Fetal growth restriction | Fetal growth restriction during the pregnancy (yes/no) | Data retrieved on inclusion |