The Investigation of the Neonates With or With Risk of COVID-19

NCT04279899 | Completed

• 1 other identifier: CHFudanU_NNICU14
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

Since December 2019, there has been an outbreak of novel coronavirus pneumonia in China. As of February 18, 2020, 72,530 cases confirmed with 2019 coronavirus disease(COVID-19) have been reported and 1,870 deaths were declared. Until now, cases of COVID-19 have been reported in 26 countries. This observational study aims to analysis the clinical features of neonates with COVID-19 and the neonates born to mother with COVID-19.

Conditions

Neonatal Infection; Perinatal Problems; Infectious Disease

Outcome Measures

Primary Outcomes (2)

• The death of newborns with COVID-19

  The date of discharge，an average of 4 weeks after the admission

• The SARS-CoV-2 infection of neonates born to mothers with COVID-19

  Neonates born to mothers with COVID-19 will be tested for SARS-CoV-2 after birth.Confirmed cases will meet the diagnosed criterion provided by National Health and Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee.

  within 7days after the admission

Secondary Outcomes (4)

• The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19

  Infants ( ≥35 weeks）are at 6 months after birth;Infants（< 35weeks） are at a corrected age of 6 months.

• The small for gestational age newborns in the neonates born to mothers with COVID-19

  at birth

• The preterm delivery of neonates born to mothers with COVID-19

  at birth

• The disease severity of neonates with COVID-19

  through study completion, estimated an average of 2 weeks

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study participants will be recruited from all the designated hospitals in in 31 provinces/municipalities of the mainland of China during SARS-CoV-2 epidemic.

You may qualify if:

• The neonates with COVID-19,or neonates born by infected mothers

You may not qualify if:

• The neonates with major anomalies

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (2)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430070, China

Location

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• Xiao T, Xia S, Zeng L, Lin G, Wei Q, Zhou W, Zhuang D, Chen X, Yi B, Li L, Mi H, Yin Z, Cheng X, Wang L, Hu X, Zhou W. A multicentre observational study on neonates exposed to SARS-CoV-2 in China: the Neo-SARS-CoV-2 Study protocol. BMJ Open. 2020 Jul 22;10(7):e038004. doi: 10.1136/bmjopen-2020-038004.

  PMID: 32699166 DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: February 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

CN (2)