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NCT Number: NCT04279899

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

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.

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Key information

Conditions

Neonatal Infection Communicable Diseases Disease Attributes Infections Infectious Disease Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Problems

Age range

0 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Maternal and Child Health Hospital of Hubei Province, Wuhan, Hubei, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The neonates with major anomalies

Treatment and study plan

Primary outcomes

  1. The death of newborns with COVID-19

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

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

    Time frame: within 7days after the admission

    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.

Secondary outcomes

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

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

    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.

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

    Time frame: at birth

    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).

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

    Time frame: at birth

    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

  4. The disease severity of neonates with COVID-19

    Time frame: through study completion, estimated an average of 2 weeks

    Infants with SARS-CoV-2 infection are classified into asymptomatic, mild infection and severe infection, according to the expert consensus provided by the Chinese

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2020
Registry last updated
Dec 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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