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

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

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.

Study Overview

• Status: Completed
• Conditions: Infectious Disease; Neonatal Infection; Perinatal Problems

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430070
      • Maternal and Child Health Hospital of Hubei Province
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• The neonates with major anomalies

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 18, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: CHFudanU_NNICU14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No