NCT05787899

Hypothermia's Effect on Hepatitis B Vaccination

Efficacy of the Hepatitis B Vaccination Post Hypothermia for Hypoxic Ischemic Encephalopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 9 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 0 Hours – 72 Hours
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Hepatitis B Vaccination
• Hypothermia, Newborn

Interventions

Type	Name	Description
OTHER	Hypothermia Protocol	Subject's who will be treated with the hypothermia protocol for Hypoxic Ischemic Encephalopathy as standard of care.

Timeline

• Start date: 2023-05-18
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-03-28
• Last updated: 2024-10-28

Locations

1 site across 1 country: United States