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OpenTrials
Completed

NCT Number: NCT05787899

Hypothermia's Effect on Hepatitis B Vaccination

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypothermia Protocol

Other

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

Primary outcomes

  1. Determine efficacy of the Hepatitis B vaccine in individuals who are treated with routine care of Hypothermia for Hypoxic Ischemic Encephalopathy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2023
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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