Hepatitis B vaccination for newborns after surgery
Official title: Influence of Delayed Vaccination of Hepatitis B Vaccine on Vaccination Safety and Immune Response of Newborns After Gastrointestinal Surgery
Run by Children's Hospital of Chongqing Medical University · NCT06023056 · Data updated 2026-11-12
This study looks at how safe and effective it is to give hepatitis B vaccinations to newborns who have had surgery, to help find the best timing for these shots.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | November 1, 2030 |
| Study ends | November 1, 2030 |
| Registry record updated | September 11, 2023 |
| Trial ID | NCT06023056 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are term neonates who have undergone staged gastrointestinal surgery and are HBsAg negative.
✕Probably not a fit
Patients who are premature, HBsAg positive, or have serious developmental defects or immune system diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the timing and safety of hepatitis B vaccination in term neonates who have undergone staged gastrointestinal surgery. The research aims to address the lack of consensus and guidelines regarding vaccination practices for these infants, as current approaches vary significantly among healthcare providers. By following a cohort of eligible newborns over a six-year period, the study will evaluate vaccination reactions and potential complications, providing valuable insights into optimal vaccination timing post-surgery.
Why it matters
Potential benefit: If successful, this study could establish clearer guidelines for hepatitis B vaccination in newborns after surgery, potentially reducing the risk of missed vaccinations and adverse reactions.
How similar studies have gone: While there is limited research on this specific topic, the study aims to fill a gap in existing literature, suggesting that it may be a novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China Recruiting
Study contacts
- Principal investigator: Hanbin Zhao, Doctor — Children's Hospital of Chongqing Medical University
- Study coordinator: Hanbin Zhao, Doctor
- Email: ddxek1994@outlook.com
- Phone: 18883370996
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.