Clinical trial NCT05451264: 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant, Premature, Diseases
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 80
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Velocity of the carotid-femoral pulse wave in m/s (VOP)
timeFrame: Inclusion
Secondary outcomes:
measure: Index increase of VOP
timeFrame: Inclusion
measure: Cardio-Radial Pulse Wave Velocity
timeFrame: Inclusion
measure: Sensitivity of the baroreflex
timeFrame: Inclusion
measure: High Frequence bare of the sympatho-vagal balance
timeFrame: Inclusion
measure: High Frequence bare of the sympatho-vagal balance
timeFrame: Inclusion
measure: Low frequence bare of the sympatho-vagal balance
timeFrame: Inclusion
measure: Low frequence bare of the sympatho-vagal balance
timeFrame: Inclusion
measure: Low Frequence/High Frequence ratio of the sympatho-vagal balance
timeFrame: Inclusion
measure: Parameters from ambulatory blood pressure measurement (ABPM)
timeFrame: During 24 hours
measure: Other factors associated with the risk of early hypertension: quality of life
timeFrame: Data retrieved on inclusion
measure: Other factors associated with the risk of early hypertension: presence of overweight
timeFrame: Data retrieved on inclusion
measure: Other factors associated with the risk of early hypertension: etnicity
timeFrame: Data retrieved on inclusion
measure: Other factors associated with the risk of early hypertension: daily physical activity
timeFrame: Data retrieved on inclusion
measure: Other factors associated with the risk of early hypertension: Fetal growth restriction
timeFrame: Data retrieved on inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: APHP
name: Chérine Chérine, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: