Enterovirus Infection During Perinatal Period Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 6500 |
| Est. completion date | December 25, 2022 |
| Est. primary completion date | May 20, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Bayi Children's Hospital, Seventh Medical Center, PLA general hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Bayi Children's Hospital Affiliated to PLA Army General Hospital, China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Detection of enterovirus | Detection of the rate of enterovirus infection and identify the genotype of enterovirus. | 42 days | |
| Secondary | Detection of antibodies of enterovirus | Detection of IgG antibodies of enterovirus | 42 days |