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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 1\. Term neonates; 2. Underwent staged gastrointestinal surgery; 3. HBsAg-; 4. No immune system disease; 5.no serious defect of heart, brain, liver, kidney and other organs.

Locations
Other Locations
China
Children's Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Hanbin Zhao, Doctor
ddxek1994@outlook.com
18883370996
Backup
yi wang, Doctor
wy757311@hotmail.com
17338332901
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2030-11-01
Participants
Target number of participants: 180
Treatments
Delayed vaccination group after gastrointestinal surgery
Newborns undergoing gastrointestinal surgery are delayed from receiving hepatitis B vaccination in the vaccination institutions due to the impact of surgery.
The group of vaccination on time after gastrointestinal surgery
Newborns undergoing gastrointestinal surgery shall be vaccinated with hepatitis B vaccine on time by vaccination institutions.
Control group
Children who are free of disease and have vaccination and physical examination on time.
Sponsors
Leads: Children's Hospital of Chongqing Medical University

This content was sourced from clinicaltrials.gov