Hypothermia's Effect on Hepatitis B Vaccination

Medical University of South Carolina (MUSC)

Status

Completed

Conditions

Hepatitis B Vaccination

Hypothermia, Newborn

Hypoxic-Ischemic Encephalopathy

Treatments

Other: Hypothermia Protocol

Study type

Observational

Funder types

Other

Identifiers

NCT05787899

Pro00126670

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

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.