Table 2.
n (% of available data)/Median (IQR) |
p-value vs no NDI | ||
---|---|---|---|
Outcome group (n=) | NDI-free survival (n = 112) | Death/NDI (n = 55) | |
Encephalopathy parameters | |||
Severe Sarnat at randomization | 16 (14.3) | 23 (41.8) | 0.0001 |
Documented seizures | 46 (41.4) | 40 (72.7) | 0.0001 |
Esophageal temperature at TH initiation (°C) | 34.5 (33.5–36.1) | 33.5 (32.7–36.0) | 0.007 |
Anticonvulsant medications | |||
Phenobarbital | 39 (34.8) | 37 (67.3) | 0.0002 |
Lorazepam (as anticonvulsant) | 14 (12.5) | 8 (14.5) | 0.70 |
Levetiracetam | 6 (5.4) | 7 (12.7) | 0.11 |
Other anticonvulsant | 8 (7.1) | 6 (10.9) | 0.39 |
Analgesic medications | |||
Morphine | 39 (34.8) | 33 (60.0) | 0.002 |
Fentanyl | 21 (18.8) | 10 (18.2) | 0.90 |
Midazolam | 33 (29.5) | 15 (27.3) | 0.77 |
Other analgesic | 15 (13.4) | 9 (16.4) | 0.62 |
Inotrope exposure | 45 (40.2) | 33 (60.0) | 0.016 |
Median mattress temperature by epoch | |||
0–6 h | 33.0 (29.0–35.0) | 34.5 (33.8–36.0) | <0.0001 |
6–24 h | 32.0 (30.0–34.5) | 33.5 (32.0–36.2) | <0.0001 |
24–48 h | 30.5 (28.0–32.5) | 33.0 (31.0–34.5) | <0.0001 |
48–72 h | 32.0 (29.0–34.0) | 33.0 (32.0–34.5) | 0.002 |
Organ involvement | |||
Oliguria/anuria | 47 (42.0) | 44 (80.0) | <0.0001 |
Liver dysfunction | 69 (61.6) | 43 (78.2) | 0.038 |
DIC | 38 (33.9) | 31 (56.4) | 0.005 |
Hypoglycemia | 30 (26.8) | 20 (36.4) | 0.17 |
Hypotension | 36 (32.1) | 26 (47.3) | 0.056 |
Respiratory support | 96 (85.7) | 54 (98.2) | 0.025 |
Total organ involvement score | 3 (2–4) | 4 (3–5) | <0.0001 |
Sarnat after rewarming | |||
Mild | 72 (66.1) | 6 (10.9) | <0.0001 |
Moderate | 34 (31.2) | 26 (47.3) | |
Severe | 3 (2.8) | 15 (27.3) | |
Missing/Dieda | 3 (2.8) | 8 (14.5) | – |
Comparison of average mattress temperatures (MT) by epoch of therapeutic hypothermia (TH) as well as evidence of encephalopathy and organ dysfunction by long-term outcome. Infants who died or survived with moderate-severe neurodevelopmental impairment (NDI) were more likely to have severe encephalopathy at randomization, documented seizures, evidence of end-organ dysfunction, a higher likelihood of being exposed to anticonvulsant medications, particularly phenobarbital, as well as morphine and inotropes. Infants who died or survived with NDI also had significantly higher average MTs across all time epochs, though only a trend was seen between survivors at 48–72 h. Bolded values indicate p-value <0.05 compared to the NDI-free survival group after adjustment for duration of cooling, where those that survived with NDI or died were considered as separate factors within the same regression models. Binary outcomes were compared with generalized estimated equations (GEE) logistic regression, and continuous outcomes by GEE linear regression. All comparisons are unadjusted except for TH treatment duration.
aSarnat exam was not documented after rewarming in 11 infants: 3 without NDI, 2 with NDI, and 5 who died. MT: mattress temperature; IQR: interquartile range; NDI: neurodevelopmental impairment; ALT: alanine aminotransferase; AST: aspartate aminotransferase; DIC: disseminated intravascular coagulopathy.