Enterovirus Surveillance During the Perinatal Period

May 8, 2020 updated by: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Establishment and Application of the National Surveillance Network for Enterovirus During the Perinatal Period

Neonates could be infected by non-polio enterovirus easily. Some of the neonates may develop fatal complications within one week. The objective of this study were as following: 1.To understand the composition and epidemiological characteristics of enterovirus infection in pregnant women in some areas of China; 2.To understand the transmission from mother to their neonates; 3.To understand the pathogenic spectrum composition, epidemiological characteristics and clinical characteristics of enterovirus infection in neonates; 4.To understand the genetic variation and changes of enteroviruses; 5.To establish a quality management system for maternal and neonatal enterovirus laboratory testing and monitoring.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

6500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100700
        • Bayi Children's Hospital, Seventh Medical Center, PLA general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Three population would be studied. 1. General parturient; 2. Puerpera with fever; 3, Febrile newborns.

Description

Inclusion Criteria:

  • 1. General parturient: on the first day of the third week of each month, all parturients and their newborns admitted to the hospital (day shift 8:00-18:00) within that day; 2. Puerpera with fever: all puerperas with fever (body temperature >=37.5 degree C) and their newborns were included in summer and autumn (from May); 3. Febrile newborns: those included in summer and autumn (from May) with the following clinical characteristics: fever >=37.5 degree C, lasting for more than one day. And sign the informed consent form with the consent of the guardian.

Exclusion Criteria:

  • 1. Pregnant women with urinary tract infection, chorioamnionitis and bacterial infection; 2. Puerpera with fever due to urinary tract infection, chorioamnionitis and bacterial infection; 3. Newborns infected with other pathogens.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General parturient
Observe the enterovirus infection in general parturients and their neonates.
Other: No intervention
No intervention
Puerpera with fever
Observe the enterovirus infection in puerpera with fever and their neonates.
Other: No intervention
No intervention
Febrile newborns
Observe the enterovirus infection in neonates
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of enterovirus
Time Frame: 42 days
Detection of the rate of enterovirus infection and identify the genotype of enterovirus.
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of antibodies of enterovirus
Time Frame: 42 days
Detection of IgG antibodies of enterovirus
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

May 20, 2020

Primary Completion (ANTICIPATED)

May 20, 2021

Study Completion (ANTICIPATED)

December 25, 2022

Study Registration Dates

First Submitted

May 8, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (ACTUAL)

May 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2020

Last Update Submitted That Met QC Criteria

May 8, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bayichildren's-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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