Clinical trial NCT04279899: The Investigation of the Neonates With or With Risk of COVID-19
Official title: A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Infection
Perinatal Problems
Infectious Disease
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 22
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* The neonates with major anomalies

Primary outcomes:
measure: The death of newborns with COVID-19
timeFrame: The date of discharge，an average of 4 weeks after the admission
measure: The SARS-CoV-2 infection of neonates born to mothers with COVID-19
timeFrame: within 7days after the admission
Secondary outcomes:
measure: The Chinese standardized Denver Developmental Screening Test (DDST) in neonates with or with risk of COVID-19
timeFrame: Infants ( ≥35 weeks）are at 6 months after birth;Infants（< 35weeks） are at a corrected age of 6 months.
measure: The small for gestational age newborns in the neonates born to mothers with COVID-19
timeFrame: at birth
measure: The preterm delivery of neonates born to mothers with COVID-19
timeFrame: at birth
measure: The disease severity of neonates with COVID-19
timeFrame: through study completion, estimated an average of 2 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Maternal and Child Health Hospital of Hubei Province
state: Hubei
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
References:
citation: 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.