Hepatitis B Vaccination After Neonatal Surgery
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ClinicalTrials.gov Identifier: NCT06023056 |
Recruitment Status :
Recruiting
First Posted : September 5, 2023
Last Update Posted : September 11, 2023
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Condition or disease |
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Vaccination Reaction Hepatitis B Virus Infection Digestive System Disorders of Fetus and Newborn Blood Transfusion Complication Hepatitis B Vaccine Adverse Reaction |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 180 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
Official Title: | Influence of Delayed Vaccination of Hepatitis B Vaccine on Vaccination Safety and Immune Response of Newborns After Gastrointestinal Surgery |
Actual Study Start Date : | November 1, 2022 |
Estimated Primary Completion Date : | November 1, 2030 |
Estimated Study Completion Date : | November 1, 2030 |
Group/Cohort |
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Delayed vaccination group after gastrointestinal surgery
Newborns undergoing gastrointestinal surgery are delayed from receiving hepatitis B vaccination in the vaccination institutions due to the impact of surgery.
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The group of vaccination on time after gastrointestinal surgery
Newborns undergoing gastrointestinal surgery shall be vaccinated with hepatitis B vaccine on time by vaccination institutions.
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Control group
Children who are free of disease and have vaccination and physical examination on time.
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- Prenatal hepatitis B surface markers [ Time Frame: 1 month ]Prenatal hepatitis B surface makers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) of mothers and childrens. Measurement of relevant indicators using Roche chemiluminescence method.
- Newborn condition [ Time Frame: 1 month ]Surface markers of hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) in newborn.
- Vaccination time [ Time Frame: up to 2 years ]Time for subjects to receive three doses of hepatitis B vaccine
- Adverse reactions [ Time Frame: 2 years ]Whether there are vaccine related adverse reactions after vaccination: fever, urticaria, local pain, erythema, induration, atc.
- Immune effect of vaccine [ Time Frame: up to 2 years ]Results of hepatitis B surface markers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) at the age of 1 and 2
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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06023056
Contact: Hanbin Zhao, Doctor | 18883370996 | ddxek1994@outlook.com | |
Contact: yi wang, Doctor | 17338332901 | wy757311@hotmail.com |
China, Chongqing | |
Children's Hospital of Chongqing Medical University | Recruiting |
Chongqing, Chongqing, China, 400014 | |
Contact: Hanbin Zhao 18883370996 ddxek1994@outlook.com |
Principal Investigator: | Hanbin Zhao, Doctor | Children's Hospital of Chongqing Medical University |
Responsible Party: | Hanbin Zhao, Principal Investigator, Children's Hospital of Chongqing Medical University |
ClinicalTrials.gov Identifier: | NCT06023056 |
Other Study ID Numbers: |
chcmuzhb20221114 |
First Posted: | September 5, 2023 Key Record Dates |
Last Update Posted: | September 11, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | We will decide whether to open the case according to the willingness to finally include the case. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hepatitis B Vaccination Reaction Hepatitis B Vaccine Adverse Reaction Neonatal surgery Gastrointestinal Surgery |
Hepatitis A Hepatitis B Herpesviridae Infections Hepatitis Digestive System Diseases Gastrointestinal Diseases Fetal Diseases Transfusion Reaction Liver Diseases Hepatitis, Viral, Human Virus Diseases Infections |
Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Hematologic Diseases Immune System Diseases Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |