Clinical trial Recruiting at 1 site Observational

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 typeObservational
SexAll
Enrollment180 (estimated)
SponsorChildren's Hospital of Chongqing Medical University
Academic / other
Locations1 site (Chongqing, Chongqing Municipality)
StatusRecruiting
StartedNovember 1, 2022
Main results expectedNovember 1, 2030
Study endsNovember 1, 2030
Registry record updatedSeptember 11, 2023
Trial IDNCT06023056 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

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.