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Enterovirus Surveillance During the Perinatal Period

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04385134
Enrollment
6500
Registered
2020-05-12
Start date
2020-05-20
Completion date
2022-12-25
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterovirus Infection During Perinatal Period

Brief summary

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Detection of enterovirus42 daysDetection of the rate of enterovirus infection and identify the genotype of enterovirus.

Secondary

MeasureTime frameDescription
Detection of antibodies of enterovirus42 daysDetection of IgG antibodies of enterovirus

Countries

China

Contacts

Primary ContactZhichun Feng, Prof
fengzhichun81@163.com+86(10) 66721786
Backup ContactLu Zhuang, PhD
zhlu1986@163.com+86(10) 66721667

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026