NCT05787899Completed
Hypothermia's Effect on Hepatitis B Vaccination
Efficacy of the Hepatitis B Vaccination Post Hypothermia for Hypoxic Ischemic Encephalopathy
Source: ClinicalTrials.gov · Last updated 28 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 9 (actual)
- First submitted
- 15 Mar 2023
- Start date
- 18 May 2023
- Primary completion date
- 1 Oct 2024
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Hepatitis B
- NCT number
- NCT05787899
What you commit to
- Study type: Observational
- Participants enrolled: 9
- From 18 May 2023 to the primary completion date, 1 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- \- Positive maternal Hepatitis B status during pregnancy
Who the study is looking for
- \> 34 weeks' gestation at birth as measured by best obstetrical estimates
- \> 1500 grams birth weight
- Clinical signs of asphyxia or documented periods of hypoxic ischemia with no cyanotic cardiac malformations and no known congenital infections.
- Documented period of hypoxic ischemia:
- Venous Cord gas pH \< 7.0 or initial newborn blood gas pH \< 7.1
- Base deficit \> 13 on venous cord gas or initial newborn blood gas
- Apgar score \< 5 at 10 minutes
- Prolonged, sustained fetal bradycardia (HR \<80) for \> 15 minutes in utero by doppler or fetal heart rate monitoring
- Need for continued resuscitation after 5 minutes (bag-valve mask ventilation with/or without chest compressions) due to the absence of respiratory effort
- Documented postnatal oxygen saturation \< 70% or PaO2 \< 35 for \> 20 minutes by 2 ABGs, not due to cyanotic heart disease, accompanied by hypotension (mean BP\< 35), cardiac arrest with chest compressions, or hemorrhage (requiring 20cc/kg volume replacement)
- Parental willingness for infant to receive Hepatitis B vaccine.
Age in the registry: 0 hours to 72 hours · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.