Table 1.
Phase I Study (n=24) | Phase II Study (n=24) | |
---|---|---|
Gestational Age at Birth (completed), wks | 39 (36 – 42) | 39 (36 – 41) |
Birthweight, kg | 3.47 (1.92 – 4.08) | 3.39 (2.68 – 4.71) |
Female, n (%) | 12 (50%) | 14 (58%) |
APGAR | ||
5 min | 3 (0 – 8) | 3 (0 – 7) |
10 min | 4 (0 – 8) | 5 (1 – 8) |
First arterial or capillary pH | 6.90 (6.72 – 7.23) | 6.91 (6.70 – 7.29) |
Base Deficit, mmol/L | −16 (−27 – −10) | −17 (−33 – −2) |
Crmax, mg/dL | 0.9 (0.6 – 2.8) | 1.0 (0.6 – 3.5) |
Crmax >1.4 mg/dL, n (%) | 1 (4%) | 5 (21%) |
ALTmax, U/L | 65 (13 – 692) | 62 (14 – 926) |
ALTmax >100 U/L, n (%) | 8 (33%) | 10 (42%) |
Intubation >12h, n (%) | 16 (67%) | 17 (71%) |
Clinical Seizure, n (%) | 9 (38%) | 8 (33%) |
Hypotension requiring inotrope, n (%) | 10 (42%) | 9 (38%) |
Death during hospitalization, n (%) | 0 (0%) | 2 (8%) |
All data are median (range) or number of patients (%). Crmax, maximum serum creatinine during study period; ALTmax, maximum alanine aminotransferse during study period.