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)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Infant, Premature, Diseases

Treatments: Diagnostic Test: blood pressure measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT05451264

APHP211326

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Hydrocortisone

Experimental group

Description:

During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).

Treatment:

Diagnostic Test: blood pressure measurement

Placebo

Placebo Comparator group

Description:

During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).

Treatment:

Diagnostic Test: blood pressure measurement