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Effect of Sildenafil in association to Hypothermia on survival without brain lesions In term Neonates with hypoxic-ischemic Encephalopathy: a randomized, double-blinded, placebo-controlled, multicenter trial
EU CTIS ID: 2023-508928-35-00
What this study is testing
Step 1: - Main objective will find to study pharmacokinetics features of IV sildenafil in neonates with HIE and treated by controlled hypothermia. Step 2: - Main objective will find to demonstrate the superiority of IV sildenafil and controlled hypothermia compared to Placebo and controlled hypothermia, on survival without brain lesions on MRI at discharge, in neonates born after 36 weeks of gestation.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Neonates born at or after 36 weeks’ gestation, treated by therapeutic servo-controlled hypothermia (33.5 +/- 0.5 °C) for neonatal HIE,
- Experimental treatment will be started > 1h of active hypothermia and <12h of life
- Social security coverage
- Informed written consent of one of the two holders of parental authority
You likely can't join if
- Chromosomal aberrations and major malformations evidenced after birth
- Decision for “comfort care only” before study drug administration
- Severe clinical conditions including uncontrolled hemorrhagic syndrome, severe hemodynamic failure at initiation
- Known hypersensitivity to the active substance or to any of the excipients
- Concomitant administration of nitrates or nitric oxide donors, Inhaled Nitric Oxide (NO), other PDE5 inhibitors, inhibitors of CYP3A4 (eg, ketoconazole, itraconazole, ritonavir)
- Participation in another interventional study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.