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NCT05787899 · ClinicalTrials.gov registry record
Hypothermia's Effect on Hepatitis B Vaccination
A clinical trial, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- 9
- Enrollment target
NCT05787899: Completed study, sponsored by Medical University of South Carolina.
NCT05787899 is a clinical trial that has completed, run by Medical University of South Carolina. The registered enrollment target is 9 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05787899 has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- 9 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Hypothermia Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-05-18 |
| Est. Completion | 2024-10-01 |
What the finished NCT05787899 record still lists
NCT05787899 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 9 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Hypothermia Protocol is the first listed.
NCT05787899 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05787899 about?
NCT05787899 is a clinical study titled "Hypothermia's Effect on Hepatitis B Vaccination". 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 serie...
What is the current status of trial NCT05787899?
This trial is currently completed. The enrollment target is 9 participants. The study started on 2023-05-18. Estimated completion is 2024-10-01.
What interventions are being tested in trial NCT05787899?
The interventions under investigation include: Hypothermia Protocol (OTHER).
Who is sponsoring clinical trial NCT05787899?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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