Hepatitis B vaccination for newborns after surgery
Influence of Delayed Vaccination of Hepatitis B Vaccine on Vaccination Safety and Immune Response of Newborns After Gastrointestinal Surgery
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 |
|---|---|
| Enrollment | 180 (estimated) |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06023056 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are term neonates who have undergone staged gastrointestinal surgery and are HBsAg negative.
Not a fit: Patients who are premature, HBsAg positive, or have serious developmental defects or immune system diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Chongqing, Chongqing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.