Hypothermia's Effect on Hepatitis B Vaccination

Completed

• Conditions: Hypothermia, Newborn; Hypoxic-Ischemic Encephalopathy; Hepatitis B Vaccination
• Interventions: Other: Hypothermia Protocol

• Registration Number: NCT05787899
• Lead Sponsor: Medical University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Study Start: 2023-05-18
• Status Verified: 2024-10
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hypothermia Protocol	Hypothermia Protocol	-

Primary Outcome Measures

Name	Time	Method
Determine efficacy of the Hepatitis B vaccine in individuals who are treated with routine care of Hypothermia for Hypoxic Ischemic Encephalopathy	18 months	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States