Hypothermia's Effect on Hepatitis B Vaccination

NCT05787899 | Completed

• 1 other identifier: Pro00126670
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy; Hepatitis B Vaccination; Hypothermia, Newborn

Keywords

Hypoxic Ischemic Encephalopathy; Hepatitis B vaccination

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hypothermia Protocol

Other: Hypothermia Protocol

Interventions

Hypothermia Protocol OTHER

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

Hypothermia Protocol

Eligibility Criteria

• Age: 0 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• \> 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.

You may not qualify if:

• \- Positive maternal Hepatitis B status during pregnancy

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Hypothermia

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: May 18, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)