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)

Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature, Diseases
• Intervention / Treatment: Diagnostic test: blood pressure measurement

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Robert Debré Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrocortisone; During the PREMILOC trial, patients received hydrocortisone (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).	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.
Placebo Comparator: Placebo; During the PREMILOC trial, patients received placebo (0.5mg/kg/12h for 7 days and 0.5mg/kg/24h for 3 days).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Chérine Chérine, MD PhD, APHP

Publications and helpful links

General Publications

• Benzouid C, Bokov P, Coste P, Azonaha S, Diallo K, Guilmin-Crepon S, Baud O, Biran V, Delclaux C. Hydrocortisone administration in preterm infants is not associated with adverse cardiovascular outcomes in childhood. Pediatr Res. 2026 Jan 9. doi: 10.1038/s41390-025-04732-4. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): July 11, 2024
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: July 5, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Premature, Diseases; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Physical Examination; Blood Pressure Determination
• Other Study ID Numbers: APHP211326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No