Actively Recruiting

All Genders
Healthy Volunteers
NCT06023056

Hepatitis B Vaccination After Neonatal Surgery

Led by Children's Hospital of Chongqing Medical University · Updated on 2023-09-11

180

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Hepatitis B Vaccination After Neonatal Surgery

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Term neonates
  • Underwent staged gastrointestinal surgery
  • HBsAg negative before initial operation
  • No immune system diseases
  • No serious defects of heart, brain, liver, kidney, or other organs
Not Eligible

You will not qualify if you...

  • Premature infants
  • HBsAg positive
  • Presence of immune system diseases
  • Serious defects of heart, brain, liver, kidney, or other organs
  • Lost to follow-up

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400014

Actively Recruiting

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Research Team

H

Hanbin Zhao, Doctor

CONTACT

Y

yi wang, Doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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