Enterovirus Surveillance During the Perinatal Period

NCT04385134 | Unknown

• 1 other identifier: Bayichildren's-02
• Study Type: observational
• Target: 6,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Enterovirus Infection During Perinatal Period

Outcome Measures

Primary Outcomes (1)

• Detection of enterovirus

  Detection of the rate of enterovirus infection and identify the genotype of enterovirus.

  42 days

Secondary Outcomes (1)

• Detection of antibodies of enterovirus

  42 days

Study Arms (3)

General parturient

Observe the enterovirus infection in general parturients and their neonates.

Other: No intervention

Puerpera with fever

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

Other: No intervention

Febrile newborns

Observe the enterovirus infection in neonates

Other: No intervention

Interventions

No intervention OTHER

No intervention

Febrile newborns; General parturient; Puerpera with fever

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Three population would be studied. 1. General parturient; 2. Puerpera with fever; 3, Febrile newborns.

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Beijing, Beijing Municipality, 100700, China

Location

Central Study Contacts

Zhichun Feng, Prof

CONTACT

+86(10) 66721786; fengzhichun81@163.com

Lu Zhuang, PhD

CONTACT

+86(10) 66721667; zhlu1986@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: May 20, 2020
• Primary Completion: May 20, 2021
• Study Completion: December 25, 2022
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)