Influence of Delayed Vaccination of Hepatitis B Vaccine on Vaccination Safety and Immune Response of Newborns After Gastrointestinal Surgery

What this Trial Is About

This research aims to study the safety and immune response of the hepatitis B vaccine when given to newborns after gastrointestinal surgery. The study addresses a common concern about whether newborns can receive the hepatitis B vaccine on time following neonatal surgery, as current practices vary without clear evidence or guidelines. It focuses on newborns who have undergone staged gastrointestinal surgeries and explores the timing of vaccination and associated reactions to provide clinical evidence for vaccination programs after surgery. Newborns who meet the criteria are divided into groups based on whether they receive the hepatitis B vaccine on time or with a delay after surgery, along with a control group of healthy children vaccinated on schedule. The study collects data on vaccination timing, adverse reactions, and hepatitis B surface antibody levels before each surgery and at ages one and two. Serum samples are also tested for HBV DNA. The study period includes follow-up up to two years, with evaluations at one and two years after starting. Participants will be monitored through regular follow-ups to record vaccination details and any adverse reactions. Researchers will gather data on hepatitis B markers from both the children and their mothers before delivery and throughout the study. Safety is evaluated by noting any serious incidents such as hospitalizations. The total study duration includes a long-term follow-up, with data management and quality control measures in place to ensure accurate and secure information collection.

Hepatitis B Vaccination After Neonatal Surgery