Hepatitis B Vaccination After Neonatal Surgery

NCT06023056 | Recruiting

• 1 other identifier: chcmuzhb20221114
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccination Reaction; Hepatitis B Virus Infection; Digestive System Disorders of Fetus and Newborn; Blood Transfusion Complication; Hepatitis B Vaccine Adverse Reaction

Keywords

Hepatitis B Vaccination Reaction; Hepatitis B Vaccine Adverse Reaction; Neonatal surgery; Gastrointestinal Surgery

Outcome Measures

Primary Outcomes (5)

• Prenatal hepatitis B surface markers

  Prenatal hepatitis B surface makers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) of mothers and childrens. Measurement of relevant indicators using Roche chemiluminescence method.

  1 month

• Newborn condition

  Surface markers of hepatitis B (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) in newborn.

  1 month

• Vaccination time

  Time for subjects to receive three doses of hepatitis B vaccine

  up to 2 years

• Adverse reactions

  Whether there are vaccine related adverse reactions after vaccination: fever, urticaria, local pain, erythema, induration, atc.

  2 years

• Immune effect of vaccine

  Results of hepatitis B surface markers (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb) at the age of 1 and 2

  up to 2 years

Study Arms (3)

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.

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.

Control group

Children who are free of disease and have vaccination and physical examination on time.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Follow up the neonates who live in the medical institution and meet the inclusion criteria. The end point of the study is 6 years after enrollment. Two mid-term evaluations will be conducted one year and two years after the start of the study. This project applies for funding until the mid-term evaluation of the first year. The follow-up research funds will be supported by the follow-up projects or self raised funds. The criteria for withdrawal from the cohort were: during the study period, the children were infected with hepatitis B virus due to other reasons such as "surgery, blood transfusion, trauma", or diagnosed with immune related diseases during the follow-up period.

You may qualify if:

• \. 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.

You may not qualify if:

• \. Premature; 2. HBsAg+; 3. Having immune system diseases; 4. Having serious defect of heart, brain, liver, kidney and other organs; 5. Lost patients.

Sponsors & Collaborators

• Children's Hospital of Chongqing Medical University: lead

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (2)

• National Center for Immunization and Respiratory Diseases. General recommendations on immunization --- recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011 Jan 28;60(2):1-64.

  PMID: 21293327 BACKGROUND

• Szilagyi PG, Rodewald LE. Missed opportunities for immunizations: a review of the evidence. J Public Health Manag Pract. 1996 Winter;2(1):18-25. doi: 10.1097/00124784-199600210-00005.

  PMID: 10186652 BACKGROUND

MeSH Terms

Conditions

Hepatitis B; Transfusion Reaction

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Hanbin Zhao, Doctor

  Children's Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanbin Zhao, Doctor

CONTACT

18883370996; ddxek1994@outlook.com

yi wang, Doctor

CONTACT

17338332901; wy757311@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: September 5, 2023
• Study Start: November 1, 2022
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

CN (1)