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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrocortisone | Experimental | During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). |
|
| Placebo | Placebo Comparator | During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood pressure measurement | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chérine Chérine, MD PhD | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Debre Hospital | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41513980 | Result | Benzouid C, Bokov P, Coste P, Azonaha S, Diallo K, Guilmin-Crepon S, Baud O, Biran V, Delclaux C. Hydrocortisone administration in preterm infants is not associated with adverse cardiovascular outcomes in childhood. Pediatr Res. 2026 Jan 9. doi: 10.1038/s41390-025-04732-4. Online ahead of print. |
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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
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The treatment having been received previously in the PREMILOC trial, no one knows which treatment the patients received.
|
| 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 |
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001795 | Blood Pressure Determination |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D010808 | Physical Examination |
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