Clinical trial NCT05787899: Hypothermia's Effect on Hepatitis B Vaccination
Official title: Efficacy of the Hepatitis B Vaccination Post Hypothermia for Hypoxic Ischemic Encephalopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic-Ischemic Encephalopathy
Hepatitis B Vaccination
Hypothermia, Newborn
Keywords: Hypoxic Ischemic Encephalopathy
Hepatitis B vaccination
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 9
Sex: ALL
Minimum age (years): 0
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypothermia protocol is only approved for HIE in newborn infants and thus only newborn infants will be subjects in this study. We enroll every neonate who meets entry criteria or is referred for HIE to our institutions regardless of race and gender.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* \> 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.

Exclusion Criteria:

- Positive maternal Hepatitis B status during pregnancy

Primary outcomes:
measure: Determine efficacy of the Hepatitis B vaccine in individuals who are treated with routine care of Hypothermia for Hypoxic Ischemic Encephalopathy
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: