CompletedNot Applicable

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)

France52 participantsStarted 2023-01-23

Plain-language 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.

Who can participate

Age range7 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Velocity of the carotid-femoral pulse wave in m/s (VOP)

Timeframe: Inclusion

Trial details

NCT IDNCT05451264

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-11

View on ClinicalTrials.gov More Infant, Premature, Diseases trials