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)
Primary Purpose
Infant, Premature, Diseases
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood pressure measurement
Sponsored by
About this trial
This is an interventional prevention trial for Infant, Premature, Diseases
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
Sites / Locations
- Robert Debre HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Hydrocortisone
Placebo
Arm Description
During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
Outcomes
Primary Outcome Measures
Velocity of the carotid-femoral pulse wave in m/s (VOP)
Velocity of the carotid-femoral pulse wave in m/s measured by the SphygmoCor device.
Secondary Outcome Measures
Index increase of VOP
Index increase measured by the SphygmoCor device
Cardio-Radial Pulse Wave Velocity
Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths
Sensitivity of the baroreflex
Sensitivity of the baroreflex (up and down measurement, average; standing versus lying down: Biopac device) in ms/mmHg; 3 measures: supine, standing and deep breaths
High Frequence bare of the sympatho-vagal balance
in ms^2; 3 measures: supine, standing and deep breaths
High Frequence bare of the sympatho-vagal balance
in percent; 3 measures: supine, standing and deep breaths
Low frequence bare of the sympatho-vagal balance
in percent; 3 measures: supine, standing and deep breaths
Low frequence bare of the sympatho-vagal balance
in ms^2; 3 measures: supine, standing and deep breaths
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Parameters from ambulatory blood pressure measurement (ABPM)
Parameters from ambulatory blood pressure measurement (ABPM) (Spacelabs device) 24-hour systolic and diastolic average, day, night, systolic and diastolic nocturnal dipping
Other factors associated with the risk of early hypertension: quality of life
quality of life: PedsQL quizz
Other factors associated with the risk of early hypertension: presence of overweight
presence of overweight (yes/no)
Other factors associated with the risk of early hypertension: etnicity
ethnicity
Other factors associated with the risk of early hypertension: daily physical activity
daily physical activity: number of hours of physical activity per day
Other factors associated with the risk of early hypertension: Fetal growth restriction
Fetal growth restriction during the pregnancy (yes/no)
Full Information
NCT ID
NCT05451264
First Posted
June 17, 2022
Last Updated
February 10, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05451264
Brief 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 (PREMILOCAP)
Acronym
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
The treatment having been received previously in the PREMILOC trial, no one knows which treatment the patients received.
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hydrocortisone
Arm Type
Experimental
Arm Description
During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).
Intervention Type
Diagnostic Test
Intervention Name(s)
blood pressure measurement
Intervention Description
Completion of the physical activity and quality of life questionnaire (PedSQL adapted to the age of the child), measurement of weight and height; Measurement of VOP (Pulse wave velocity), AI (increase index) and ECG (electro cardiogram) collection at rest lying down; Stimulation test by slow breathing at 6 cycles/min for three minutes; Continuation of the measurements in a standing position for 5 minutes; Installation of blood pressure holter (MAPA) which will be kept for 24 hours and then returned by post.
Primary Outcome Measure Information:
Title
Velocity of the carotid-femoral pulse wave in m/s (VOP)
Description
Velocity of the carotid-femoral pulse wave in m/s measured by the SphygmoCor device.
Time Frame
Inclusion
Secondary Outcome Measure Information:
Title
Index increase of VOP
Description
Index increase measured by the SphygmoCor device
Time Frame
Inclusion
Title
Cardio-Radial Pulse Wave Velocity
Description
Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths
Time Frame
Inclusion
Title
Sensitivity of the baroreflex
Description
Sensitivity of the baroreflex (up and down measurement, average; standing versus lying down: Biopac device) in ms/mmHg; 3 measures: supine, standing and deep breaths
Time Frame
Inclusion
Title
High Frequence bare of the sympatho-vagal balance
Description
in ms^2; 3 measures: supine, standing and deep breaths
Time Frame
Inclusion
Title
High Frequence bare of the sympatho-vagal balance
Description
in percent; 3 measures: supine, standing and deep breaths
Time Frame
Inclusion
Title
Low frequence bare of the sympatho-vagal balance
Description
in percent; 3 measures: supine, standing and deep breaths
Time Frame
Inclusion
Title
Low frequence bare of the sympatho-vagal balance
Description
in ms^2; 3 measures: supine, standing and deep breaths
Time Frame
Inclusion
Title
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Description
Low Frequence/High Frequence ratio of the sympatho-vagal balance
Time Frame
Inclusion
Title
Parameters from ambulatory blood pressure measurement (ABPM)
Description
Parameters from ambulatory blood pressure measurement (ABPM) (Spacelabs device) 24-hour systolic and diastolic average, day, night, systolic and diastolic nocturnal dipping
Time Frame
During 24 hours
Title
Other factors associated with the risk of early hypertension: quality of life
Description
quality of life: PedsQL quizz
Time Frame
Data retrieved on inclusion
Title
Other factors associated with the risk of early hypertension: presence of overweight
Description
presence of overweight (yes/no)
Time Frame
Data retrieved on inclusion
Title
Other factors associated with the risk of early hypertension: etnicity
Description
ethnicity
Time Frame
Data retrieved on inclusion
Title
Other factors associated with the risk of early hypertension: daily physical activity
Description
daily physical activity: number of hours of physical activity per day
Time Frame
Data retrieved on inclusion
Title
Other factors associated with the risk of early hypertension: Fetal growth restriction
Description
Fetal growth restriction during the pregnancy (yes/no)
Time Frame
Data retrieved on inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chérine BENZOUID-HACHEMAOUI, MD PhD
Phone
01 40 03 41 97
Ext
+33
Email
cherine.benzouid@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe DELCLAUX, MD PhD
Phone
01 40 03 41 90
Ext
+33
Email
christophe.delclaux@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chérine Chérine, MD PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chérine BENZOUID-HACHEMAOUI, MD PhD
Phone
+33 1 40 03 41 97
Ext
+33
Email
cherine.benzouid@aphp.fr
First Name & Middle Initial & Last Name & Degree
Christophe Delclaux, MD PhD
Phone
+33 1 40 03 41 90
Ext
+33
Email
christophe.declaux@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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)
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