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NCT06023056
Hepatitis B Vaccination After Neonatal Surgery
trial in Vaccination Reaction in 180 participants. Currently enrolling.
1 November 2030
Quick facts
| Lead sponsor | Children's Hospital of Chongqing Medical University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 180 |
| Start date | 1 November 2022 |
| Primary completion | 1 November 2030 |
| Estimated completion | 1 November 2030 |
| Sites | 1 location across China |
Conditions studied
- Vaccination Reaction — all drugs for Vaccination Reaction →
- Hepatitis B Virus Infection — all drugs for Hepatitis B Virus Infection →
- Digestive System Disorders of Fetus and Newborn — all drugs for Digestive System Disorders of Fetus and Newborn →
- Blood Transfusion Complication — all drugs for Blood Transfusion Complication →
Sponsor
Children's Hospital of Chongqing Medical University
Who can join
Eligibility, any sex, with Vaccination Reaction or Hepatitis B Virus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06023056 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Chongqing Medical University
- Last refreshed: 11 September 2023
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