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

Infectious Disease Clinical Trial

Official title:

A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04279899
• Other study ID #: CHFudanU_NNICU14
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Given that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads rapidly and is contagious to the general population, all the suspected or confirmed newborns will be admitted to the neonatal departments in designated hospitals of China. In this study, the diagnosis of neonatal SARS-CoV-2 infection is based on the criterion provided by National Health Commission and the Chinese perinatal-neonatal SARS-CoV-2 Committee. All samples will be treated as biohazardous material. SARS-CoV-2 will be tested in blood, cord blood, amniotic fluid, placenta, respiratory tract, stool, urine from mothers or neonates. The medical information questionnaires are classified into maternal and neonatal version, which include demographic details, epidemical history, clinical manifestations, tests collected time and results, imaging performed time and results and therapeutic data. Two researchers independently checked and recorded the data to ensure the accuracy of the data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• The neonates with major anomalies

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease
• Neonatal Infection
• Perinatal Problems

Locations

Country	Name	City	State
China	Children Hospital of Fudan University	Shanghai	Shanghai
China	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The death of newborns with COVID-19		The date of discharge,an average of 4 weeks after the admission
Primary	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	The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19	The standardized DDST consists of 104 items and covers four areas of development: (a) personal/social, (b) fine motor/adaptive, (c) language, and (d) gross motor. In the present study, three trained professionals examined the children. The results of the DDST could be normal (no delays), suspect (2 or more caution items and/or 1 or more delays), abnormal (2 or more delays) or untestable (refusal of one or more items completely to the left of the age line or more than one item intersected by the age line in the 75-90% area). The children with suspect or abnormal results were retested 2 or 3 weeks later.	Infants ( =35 weeks)are at 6 months after birth;Infants(< 35weeks) are at a corrected age of 6 months.
Secondary	The small for gestational age newborns in the neonates born to mothers with COVID-19	The small for gestational age infant is defined as live-born infants weighting less than the 10th percentile for gestational age (22 weeks+0 day to 36 weeks+6days).	at birth
Secondary	The preterm delivery of neonates born to mothers with COVID-19	The preterm infant is defined as the gestational age less than 37weeks+0day.The gestational age range is 22 weeks+0 day to 36 weeks+6days	at birth
Secondary	The disease severity of neonates with COVID-19	Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese	through study completion, estimated an average of 2 weeks