Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children
Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 13
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Robert Debre Hospital
RECRUITING
Paris
Contact Information
Primary
Chérine BENZOUID-HACHEMAOUI, MD PhD
cherine.benzouid@aphp.fr
01 40 03 41 97
Backup
Christophe DELCLAUX, MD PhD
christophe.delclaux@aphp.fr
01 40 03 41 90
Time Frame
Start Date: 2023-01-23
Estimated Completion Date: 2024-10
Participants
Target number of participants: 80
Treatments
Experimental: Hydrocortisone
During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
Placebo_comparator: Placebo
During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris