Hypothermia's Effect on Hepatitis B Vaccination | NCT05787899

Studies
Hypothermia's Effect on Hepatitis B Vaccination

NCT05787899

Sponsor

Medical University of South Carolina

Status

Completed

Last Update Posted

Oct 28, 2024Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Hypoxic-Ischemic Encephalopathy
Hepatitis B Vaccination
Hypothermia, Newborn

Interventions

Hypothermia Protocol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 18, 2023Actual

Primary Completion Date

Oct 1, 2024Actual

Completion Date

Oct 1, 2024Actual

First Submitted Date

Mar 15, 2023

First Submission Date that Met QC Criteria

Mar 15, 2023

First Posted Date

Mar 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2024

Last Update Posted Date

Oct 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hypothermia Protocol			Other: Hypothermia Protocol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypothermia Protocol	Other	Subject's who will be treated with the hypothermia protocol for Hypoxic Ischemic Encephalopathy as standard of care.	Hypothermia Protocol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Hours

Maximum Age

72 Hours

Standard Ages

Child

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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of South Carolina		Charleston	South Carolina	29425	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020925	Hypoxia-Ischemia, Brain
D007035	Hypothermia

Ancestor Terms

ID	Term
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided