Enterovirus Surveillance During the Perinatal Period

NCT ID: NCT04385134

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

6500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-20

Study Completion Date

2022-12-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Enterovirus Infection During Perinatal Period

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

General parturient

Observe the enterovirus infection in general parturients and their neonates.

No intervention

Intervention Type OTHER

No intervention

Puerpera with fever

Observe the enterovirus infection in puerpera with fever and their neonates.

No intervention

Intervention Type OTHER

No intervention

Febrile newborns

Observe the enterovirus infection in neonates

No intervention

Intervention Type OTHER

No intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bayi Children's Hospital, Seventh Medical Center, PLA general hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhichun Feng, Prof

Role: CONTACT

+86(10) 66721786

Lu Zhuang, PhD

Role: CONTACT

+86(10) 66721667

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhichun Feng, Prof

Role: primary

+86(10) 66721786

Lu Zhuang, PhD

Role: backup

+86(10) 66721667

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Bayichildren's-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.