|Title||Differences in patient characteristics and care practices between two trials of therapeutic hypothermia.|
|Publication Type||Journal Article|
|Year of Publication||2019|
|Authors||Bonifacio SL, McDonald SA, Chock VY, Wusthoff CJ, Hintz SR, Laptook AR, Shankara S, Van Meurs KP|
|Date Published||2019 06|
|Keywords||Adult, Cognition Disorders, Developmental Disabilities, Female, Humans, Hypothermia, Induced, Hypoxia-Ischemia, Brain, Infant, Newborn, Male, Young Adult|
BACKGROUND: The Induced Hypothermia (IH) and Optimizing Cooling (OC) trials for hypoxic-ischemic encephalopathy (HIE) had similar inclusion criteria. The rate of death/moderate-severe disability differed for the subgroups treated with therapeutic hypothermia (TH) at 33.5 °C for 72 h (44% vs. 29%, unadjusted p = 0.03). We aimed to evaluate differences in patient characteristics and care practices between the trials.
METHODS: We compared pre/post-randomization characteristics and care practices between IH and OC.
RESULTS: There were 208 patients in the IH trial, 102 cooled, and 364 in the OC trial, 95 cooled to 33.5 °C for 72 h. In OC, neonates were less ill, fewer had severe HIE, and the majority were cooled prior to randomization. Differences between IH and OC were observed in the adjusted difference in the lowest PCO (+3.08 mmHg, p = 0.005) and highest PO (-82.7 mmHg, p < 0.001). In OC, compared to IH, the adjusted relative risk (RR) of exposure to anticonvulsant prior to randomization was decreased (RR 0.58, (0.40-0.85), p = 0.005) and there was increased risk of exposure during cooling to sedatives/analgesia (RR 1.86 (1.21-2.86), p = 0.005).
CONCLUSION: Despite similar inclusion criteria, there were differences in patient characteristics and care practices between trials. Change in care practices over time should be considered when planning future neuroprotective trials.
|Alternate Journal||Pediatr Res|
|PubMed Central ID||PMC6857796|
|Grant List||UG1 HD027853 / HD / NICHD NIH HHS / United States |
UG1 HD087229 / HD / NICHD NIH HHS / United States
UG1 HD027904 / HD / NICHD NIH HHS / United States
UG1 HD027880 / HD / NICHD NIH HHS / United States
K23 NS082500 / NS / NINDS NIH HHS / United States
K02 NS102598 / NS / NINDS NIH HHS / United States