Effect of Hydrocortisone on Blood Pressure in Premature Children
Study of the Effect of Hydrocortisone Administered for the Prevention of Pulmonary Bronchodysplasia (PREMILOC Trial) on the Determinants of Systemic Blood Pressure in Children
This study is testing if giving hydrocortisone to premature babies affects their blood pressure and artery health when they grow up.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 7 Years to 13 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05451264 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term effects of hydrocortisone administration during the neonatal period on systemic blood pressure in children born prematurely. It aims to assess whether hydrocortisone influences pulse wave velocity, a measure of arterial stiffness, by comparing children who received hydrocortisone to those who received a placebo. The follow-up will occur approximately 10 years after the initial trial, focusing on vascular parameters in children aged 7 to 13 years. The study is conducted at the Robert Debré hospital and involves a cross-sectional analysis of previously enrolled participants.
Who should consider this trial
Good fit: Ideal candidates are children aged 7 to 13 years who were previously enrolled in the PREMILOC trial at the Robert Debré hospital.
Not a fit: Patients who were not part of the PREMILOC trial or those without social security affiliation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood pressure and cardiovascular health in children born prematurely.
How similar studies have performed: Similar studies have shown promising results regarding the effects of hydrocortisone on health outcomes in premature infants, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Robert Debre Hospital — Paris, France (Recruiting)
Study contacts
- Principal investigator: Chérine Chérine, MD PhD — Aphp
- Study coordinator: Chérine BENZOUID-HACHEMAOUI, MD PhD
- Email: cherine.benzouid@aphp.fr
- Phone: 01 40 03 41 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.