Enterovirus Surveillance During the Perinatal Period

• Conditions: Enterovirus Infection During Perinatal Period
• Interventions: Other: No intervention

• Registration Number: NCT04385134
• Lead Sponsor: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-08
• Study First Submitted QC: 2020-05-08
• Last Update Submitted: 2020-05-08
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12
• Study Start: 2020-05-20
• Primary Completion: 2021-05-20
• Study Completion: 2022-12-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Detection of enterovirus	42 days	Detection of the rate of enterovirus infection and identify the genotype of enterovirus.

Secondary Outcome Measures

Name	Time	Method
Detection of antibodies of enterovirus	42 days	Detection of IgG antibodies of enterovirus

Trial Locations

Locations (1)

Bayi Children's Hospital, Seventh Medical Center, PLA general hospital; 🇨🇳 Beijing, Beijing, China