Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04643821 | NVD in Hypothermic HIE Neonates | EARLY_PHASE1 | COMPLETED | 30 | — | — | Jan 1, 2015 | Mar 1, 2020 | Dec 4, 2020 | - | — |
PK parameters of plasma half life around first dose on day of life 1 during hypothermia, and day of life 5 during normothermia
PK parameters of serum half life around first dose on day of life 1 during hypothermia, and day of life 5 during normothermia
GSH by MRS before, immediately after and up to 6h after NVD infusion on day of life 5
| Arm | Type | Description |
|---|---|---|
| NAC 25mg/kg, calcitriol 0.05mcg/kg | EXPERIMENTAL | N-acetylcysteine 25mg/kg iv q 12h, calcitriol 0.05mcg/kg iv q 12h, for 10 days, starting within 6h of birth |
| NAC 25mg/kg, calcitriol 0.03mcg/kg | EXPERIMENTAL | N-acetylcysteine 25mg/kg iv q 12h, calcitriol 0.03mcg/kg iv q 24h, for 10 days, starting within 6h of birth |
| NAC 40mg/kg, calcitriol 0.03mcg/kg | EXPERIMENTAL | N-acetylcysteine 40mg/kg iv q 12h, calcitriol 0.03mcg/kg iv q 24h, for 10 days, starting within 6h of birth |
| Name | Type | Description |
|---|---|---|
| N-acetylcysteine, NAC, and calcitriol | DRUG | iv administration of antioxidant and active vitamin D |
Inclusion Criteria: * Neonates \> 34 weeks, \> 2000 grams, within 6h of birth with moderate to severe HIE receiving therapeutic hypothermia Exclusion Criteria: * Evidence of a congenital CNS malformation if known prior to enrollment * Evidence of neuromuscular disorder by family history * More th...