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)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 5, 2022

Keywords

ClinConnect Summary

The PREMILOCAP trial is studying how a medication called hydrocortisone, given to very premature infants, might affect their blood pressure as they grow older. Researchers want to find out if hydrocortisone influences something called Pulse Wave Velocity (PWV), which is a measure of how quickly blood flows through the arteries. This is important because very premature infants are at a higher risk of developing high blood pressure later in life. The study will look at children aged 7 to 13 years who were part of an earlier study (the PREMILOC trial) where some received hydrocortisone and others received a placebo (a harmless sugar pill).

To be eligible for this study, children need to be between 7 and 13 years old and have participated in the original PREMILOC trial at the Robert Debré site. Parents or guardians must provide consent, and the child should also agree to take part. The trial is currently looking for participants, and those who join will help researchers understand the long-term effects of hydrocortisone on blood pressure in children who were born prematurely. This research could be important for improving the health of future generations of premature infants.

Gender

ALL

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