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Enterovirus Surveillance During the Perinatal Period

B

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

Status

Unknown

Conditions

Enterovirus Infection During Perinatal Period

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04385134
Bayichildren's-02

Details and patient eligibility

About

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.

Enrollment

6,500 estimated patients

Sex

All

Ages

Under 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

6,500 participants in 3 patient groups

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

Trial contacts and locations

1

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Central trial contact

Zhichun Feng, Prof; Lu Zhuang, PhD

Data sourced from clinicaltrials.gov

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