SHINE trial - 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

Conditions

Hypoxic ischemic encephalopathy

Brief summary

Primary endpoint of step 1 will be the measured plasma concentrations of Sildenafil., Primary endpoint of step 2 will be survival without brain lesions at hospital discharge on brain MRI. The MRI will be performed between the end of rewarming (day 3.5) and day 5

Detailed description

Step 1: estimated clearance parameters and volumes of distribution for IV sildenafil, Step 1: area under the plasma sildenafil concentration-time curve and the maximum plasma sildenafil concentration achieved (individual exposure), Step 1: brain damage-free survival at hospital discharge on MRIs performed between 3.5 to 5 days and/or 10-30 days” (treatment efficacy), Step 2: Secondary end-points, related to potential benefits, will be based on changes in EEG patterns, detailed analysis of MRIs and spectroscopy, and 2-year assessment (neurodevelopmental impairment, autism spectrum disorders assessed using M-CHAT (Modified Checklist for Autism in Toddlers), PARCA-R and Parenting Stress Index-Short Form (PSI-SF)., Step 2: Secondary end-points, related to safety, will include incidence of low systemic pressure requiring hemodynamic support, and cardiac function assessment.

Related papers

No related papers found yet.

Interventions

DRUGRevatio 0.8 mg/ml solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Primary endpoint of step 1 will be the measured plasma concentrations of Sildenafil., Primary endpoint of step 2 will be survival without brain lesions at hospital discharge on brain MRI. The MRI will be performed between the end of rewarming (day 3.5) and day 5	—

Secondary

Measure	Time frame
Step 1: estimated clearance parameters and volumes of distribution for IV sildenafil, Step 1: area under the plasma sildenafil concentration-time curve and the maximum plasma sildenafil concentration achieved (individual exposure), Step 1: brain damage-free survival at hospital discharge on MRIs performed between 3.5 to 5 days and/or 10-30 days” (treatment efficacy), Step 2: Secondary end-points, related to potential benefits, will be based on changes in EEG patterns, detailed analysis of MRIs and spectroscopy, and 2-year assessment (neurodevelopmental impairment, autism spectrum disorders assessed using M-CHAT (Modified Checklist for Autism in Toddlers), PARCA-R and Parenting Stress Index-Short Form (PSI-SF)., Step 2: Secondary end-points, related to safety, will include incidence of low systemic pressure requiring hemodynamic support, and cardiac function assessment.	—

Measure

Time frame

Step 1: estimated clearance parameters and volumes of distribution for IV sildenafil, Step 1: area under the plasma sildenafil concentration-time curve and the maximum plasma sildenafil concentration achieved (individual exposure), Step 1: brain damage-free survival at hospital discharge on MRIs performed between 3.5 to 5 days and/or 10-30 days” (treatment efficacy), Step 2: Secondary end-points, related to potential benefits, will be based on changes in EEG patterns, detailed analysis of MRIs and spectroscopy, and 2-year assessment (neurodevelopmental impairment, autism spectrum disorders assessed using M-CHAT (Modified Checklist for Autism in Toddlers), PARCA-R and Parenting Stress Index-Short Form (PSI-SF)., Step 2: Secondary end-points, related to safety, will include incidence of low systemic pressure requiring hemodynamic support, and cardiac function assessment.

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Countries

France

Outcome results

None listed