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)

Infant, Premature, Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05451264
• Other study ID #: APHP211326
• Status: Recruiting
• Phase: N/A
• Start date: January 23, 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Chérine BENZOUID-HACHEMAOUI, MD PhD
• Phone: 01 40 03 41 97
• Email: cherine.benzouid[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature, Diseases

Intervention

Diagnostic Test:
• blood pressure measurement
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.

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Inclusion
Secondary	Index increase of VOP	Index increase measured by the SphygmoCor device	Inclusion
Secondary	Cardio-Radial Pulse Wave Velocity	Cardio-Radial Pulse Wave Velocity in m/s (Biopac device); 3 measures: supine, standing and deep breaths	Inclusion
Secondary	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	Inclusion
Secondary	High Frequence bare of the sympatho-vagal balance	in ms^2; 3 measures: supine, standing and deep breaths	Inclusion
Secondary	High Frequence bare of the sympatho-vagal balance	in percent; 3 measures: supine, standing and deep breaths	Inclusion
Secondary	Low frequence bare of the sympatho-vagal balance	in percent; 3 measures: supine, standing and deep breaths	Inclusion
Secondary	Low frequence bare of the sympatho-vagal balance	in ms^2; 3 measures: supine, standing and deep breaths	Inclusion
Secondary	Low Frequence/High Frequence ratio of the sympatho-vagal balance	Low Frequence/High Frequence ratio of the sympatho-vagal balance	Inclusion
Secondary	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	During 24 hours
Secondary	Other factors associated with the risk of early hypertension: quality of life	quality of life: PedsQL quizz	Data retrieved on inclusion
Secondary	Other factors associated with the risk of early hypertension: presence of overweight	presence of overweight (yes/no)	Data retrieved on inclusion
Secondary	Other factors associated with the risk of early hypertension: etnicity	ethnicity	Data retrieved on inclusion
Secondary	Other factors associated with the risk of early hypertension: daily physical activity	daily physical activity: number of hours of physical activity per day	Data retrieved on inclusion
Secondary	Other factors associated with the risk of early hypertension: Fetal growth restriction	Fetal growth restriction during the pregnancy (yes/no)	Data retrieved on inclusion