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)

NCT05451264 | Completed

• 1 other identifier: APHP211326
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature, Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Index increase of VOP

  Inclusion

• Cardio-Radial Pulse Wave Velocity

  Inclusion

• Sensitivity of the baroreflex

  Inclusion

• High Frequence bare of the sympatho-vagal balance

  Inclusion

• High Frequence bare of the sympatho-vagal balance

  Inclusion

Study Arms (2)

Hydrocortisone

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

blood pressure measurement DIAGNOSTIC_TEST

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.

Hydrocortisone; Placebo

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Absence of affiliation to a social security scheme
• Patient under state medical aid

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

Related Publications (1)

• 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.

  PMID: 41513980 RESULT

MeSH Terms

Conditions

Infant, Premature, Diseases

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Officials

• Chérine Chérine, MD PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The treatment having been received previously in the PREMILOC trial, no one knows which treatment the patients received.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 17, 2022
• First Posted: July 11, 2022
• Study Start: January 23, 2023
• Primary Completion: July 11, 2024
• Study Completion: July 11, 2024
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)