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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 (PREMILOCAP) — PREMILOCAP  

Infant, Premature, Diseases Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05451264
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Chérine BENZOUID-HACHEMAOUI, MD PhD
Phone 01 40 03 41 97
Email cherine.benzouid@aphp.fr
Status Recruiting
Phase N/A
Start date January 23, 2023
Completion date October 2024
View Details
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