Medical University of South Carolina
Charleston, South Carolina, 29425, United States
NCT Number: NCT05787899
The purpose of the research is to determine if the Hepatitis B vaccine after birth provides enough protection after cooling for Hypoxic Ischemic Encephalopathy (HIE). To do this, Hepatitis B titers (blood sample) would be taken before, during, and after administering of the Hepatitis B vaccine series to measure efficacy of the vaccine.
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All sexes
Observational
Charleston, South Carolina, 29425, United States
Despite the current research on Hypoxic Ischemic Encephalopathy (HIE), and the known effects of hypothermia on acute immune response, the effect of the hypothermia protocol for HIE on the efficacy of the Hepatitis B vaccine is still unknown. We plan to measure anti-hepatitis B surface antibodies at intervals prior, during, and after the primary Hepatitis B vaccine schedule for individuals with HIE to see if there is any effect on efficacy due to the Hypothermia protocol.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subject's who will be treated with the hypothermia protocol for Hypoxic Ischemic Encephalopathy as standard of care.
Time frame: 18 months
Response to vaccine will be measured by the previously researched protective level of anti-hepatitis B surface antibodies of ≥ 10 mIU/ml. We hypothesize that hypothermia to 33-33.5oC for 72h in near-term and term infants with Hypoxic Ischemic Encephalopathy will decrease the infant's immune response to the primary Hepatitis B vaccine series.
Medical University of South Carolina
Other
Efficacy of the Hepatitis B Vaccination Post Hypothermia for Hypoxic Ischemic Encephalopathy
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