Hepatitis B Vaccination After Neonatal Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChildren's Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Follow up the neonates who live in the medical institution and meet the inclusion criteria. The end point of the study is 6 years after enrollment. Two mid-term evaluations will be conducted one year and two years after the start of the study. This project applies for funding until the mid-term evaluation of the first year. The follow-up research funds will be supported by the follow-up projects or self raised funds. The criteria for withdrawal from the cohort were: during the study period, the children were infected with hepatitis B virus due to other reasons such as "surgery, blood transfusion, trauma", or diagnosed with immune related diseases during the follow-up period.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 3 trial groups
Group A: Delayed vaccination group after gastrointestinal surgery
Group B: The group of vaccination on time after gastrointestinal surgery
Group C: Control group

Trial outcomes

Primary outcomes

1

Prenatal hepatitis B surface markers

Prenatal hepatitis B surface makers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) of mothers and childrens. Measurement of relevant indicators using Roche chemiluminescence method.

Time frame
1 month
2

Newborn condition

Surface markers of hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) in newborn.

Time frame
1 month
3

Vaccination time

Time for subjects to receive three doses of hepatitis B vaccine

Time frame
up to 2 years
4

Adverse reactions

Whether there are vaccine related adverse reactions after vaccination: fever, urticaria, local pain, erythema, induration, atc.

Time frame
2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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