Infant, Premature, Diseases
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTblood pressure measurement
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The treatment having been received previously in the PREMILOC trial, no one knows which treatment the patients received.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Velocity of the carotid-femoral pulse wave in m/s (VOP) | Inclusion | Velocity of the carotid-femoral pulse wave in m/s measured by the SphygmoCor device. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Index increase of VOP | Inclusion | Index increase measured by the SphygmoCor device |
| Cardio-Radial Pulse Wave Velocity | Inclusion | Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths |
| Sensitivity of the baroreflex | Inclusion | 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 |
| High Frequence bare of the sympatho-vagal balance | Inclusion | in ms\^2; 3 measures: supine, standing and deep breaths |
| Low frequence bare of the sympatho-vagal balance | Inclusion | in percent; 3 measures: supine, standing and deep breaths |
| Low Frequence/High Frequence ratio of the sympatho-vagal balance | Inclusion | Low Frequence/High Frequence ratio of the sympatho-vagal balance |
| Parameters from ambulatory blood pressure measurement (ABPM) | During 24 hours | Parameters from ambulatory blood pressure measurement (ABPM) (Spacelabs device) 24-hour systolic and diastolic average, day, night, systolic and diastolic nocturnal dipping |
| Other factors associated with the risk of early hypertension: quality of life | Data retrieved on inclusion | quality of life: PedsQL quizz |
| Other factors associated with the risk of early hypertension: presence of overweight | Data retrieved on inclusion | presence of overweight (yes/no) |
| Other factors associated with the risk of early hypertension: etnicity | Data retrieved on inclusion | ethnicity |
| Other factors associated with the risk of early hypertension: daily physical activity | Data retrieved on inclusion | daily physical activity: number of hours of physical activity per day |
| Other factors associated with the risk of early hypertension: Fetal growth restriction | Data retrieved on inclusion | Fetal growth restriction during the pregnancy (yes/no) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChérine Chérine, MD PhD
APHP
Outcome results
None listed