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)
- Conditions
- Infant, Premature, Diseases
- Interventions
- Diagnostic Test: blood pressure measurement
- Registration Number
- NCT05451264
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- Absence of affiliation to a social security scheme
- Patient under state medical aid
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hydrocortisone blood pressure measurement During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days). Placebo blood pressure measurement During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Low frequence bare of the sympatho-vagal balance Inclusion in ms\^2; 3 measures: supine, standing and deep breaths
Other factors associated with the risk of early hypertension: Fetal growth restriction Data retrieved on inclusion Fetal growth restriction during the pregnancy (yes/no)
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
High Frequence bare of the sympatho-vagal balance Inclusion in percent; 3 measures: supine, standing and deep breaths
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: 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: quality of life Data retrieved on inclusion quality of life: PedsQL quizz
Other factors associated with the risk of early hypertension: etnicity Data retrieved on inclusion ethnicity
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
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
Low Frequence/High Frequence ratio of the sympatho-vagal balance Inclusion Low Frequence/High Frequence ratio of the sympatho-vagal balance
Trial Locations
- Locations (1)
Robert Debre Hospital
🇫🇷Paris, France