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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Newborn condition
Surface markers of hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) in newborn.
Vaccination time
Time for subjects to receive three doses of hepatitis B vaccine
Adverse reactions
Whether there are vaccine related adverse reactions after vaccination: fever, urticaria, local pain, erythema, induration, atc.
Sponsors and contacts
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