NCT06023056 Hepatitis B Vaccination After Neonatal Surgery
| NCT ID | NCT06023056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Chongqing Medical University |
| Condition | Vaccination Reaction |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2030-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2022-11-01 with a primary completion date of 2030-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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. Exclusion Criteria: 1\. Premature; 2. HBsAg+; 3. Having immune system diseases; 4. Having serious defect of heart, brain, liver, kidney and other organs; 5. Lost patients.
Contact & Investigator
Hanbin Zhao, Doctor
PRINCIPAL INVESTIGATOR
Children's Hospital of Chongqing Medical University
Frequently Asked Questions
Who can join the NCT06023056 clinical trial?
This trial is open to participants of all sexes, studying Vaccination Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06023056 currently recruiting?
Yes, NCT06023056 is actively recruiting participants. Contact the research team at ddxek1994@outlook.com for enrollment information.
Where is the NCT06023056 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT06023056 clinical trial?
NCT06023056 is sponsored by Children's Hospital of Chongqing Medical University. The principal investigator is Hanbin Zhao, Doctor at Children's Hospital of Chongqing Medical University. The trial plans to enroll 180 participants.