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Hepatitis B Vaccination After Neonatal Surgery

NCT06023056 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2023-09-11

No results posted yet for this study

Summary

At present, whether the hepatitis B vaccine (HBV) can be vaccinated on time after neonatal surgery has become a common problem for children's families, neonatal surgeons, and vaccination departments, but there are few relevant studies at home and abroad, and there is no corresponding guide or consensus. In the early stage, our research team investigated the vaccination plans of the vaccination units in the main urban areas of Chongqing for such children through telephone follow-up, and found that the practices of each unit were different, all based on their own experience, and there was no clear evidence to support the vaccination or should not be vaccinated, which may cause some children to miss the best vaccination time or increase the risk of vaccination. The center is a relatively large neonatal surgery center in southwest China. The diagnosis and treatment of neonatal digestive tract malformations is at the leading level in China. It can carry out various neonatal operations such as neonatal necrotizing enterocolitis, congenital anorectal malformations, and congenital megacolon. On average, it carries out more than 30 third and fourth grade neonatal gastrointestinal operations every month. It has accumulated a lot of experience in the follow-up of newborns, There is a large amount of clinical data support for children who need to be vaccinated after surgery, so it is planned to follow up the second and third doses of hepatitis B vaccine and whether there are adverse reactions related to vaccination for children who need to be vaccinated after gastrointestinal surgery in the neonatal period, and at the same time check the production of HBsAb after vaccination, The immune response and adverse reactions of hepatitis B vaccine at different time points after surgery were studied to increase clinical evidence for the determination of hepatitis B vaccine vaccination program for newborns after surgery.

Conditions

  • Vaccination Reaction
  • Hepatitis B Virus Infection
  • Digestive System Disorders of Fetus and Newborn
  • Blood Transfusion Complication
  • Hepatitis B Vaccine Adverse Reaction

Sponsors & Collaborators

  • Children's Hospital of Chongqing Medical University

    lead OTHER

Principal Investigators

  • Hanbin Zhao, Doctor · Children's Hospital of Chongqing Medical University

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2030-11-01
Completion
2030-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023056 on ClinicalTrials.gov