Hypothermia's Effect on Hepatitis B Vaccination

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787899
• Other study ID #: Pro00126670
• Status: Recruiting
• Start date: May 18, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: June 2023
• Source: Medical University of South Carolina
• Contact: Florian Capobianco, DO
• Phone: (843)-792-1414
• Email: Capobian[@]musc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Hours to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccination
• Hypothermia
• Hypothermia, Newborn
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

Other:
• Hypothermia Protocol
Subject's who will be treated with the hypothermia protocol for Hypoxic Ischemic Encephalopathy as standard of care.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine efficacy of the Hepatitis B vaccine in individuals who are treated with routine care of Hypothermia for Hypoxic Ischemic Encephalopathy	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.	18 months