Neonatal InfectionNCT04279899
The Investigation of the Neonates With or With Risk of COVID-19
An observational study of Neonatal Infection and Perinatal Problems, run by Children's Hospital of Fudan University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Neonatal Infection, Perinatal Problems, Infectious Disease
- How many people
- 22 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- The neonates with COVID-19,or neonates born by infected mothers
Who cannot join
- The neonates with major anomalies
Trial locations and contacts
2 sites in 1 country.
China2 sites
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430070
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Infection, Perinatal Problems, Infectious Disease
- Medical subject headings
- Communicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The death of newborns with COVID-19
Measured: 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.
Measured: 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
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: through study completion, estimated an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Feb 2020
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279899
- Sponsor's protocol ID
- CHFudanU_NNICU14
- Status last verified
- Dec 2023
- First submitted
- 18 Feb 2020
- Last updated
- 28 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32699166
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Observational Study of the Perinatal-neonatal Population With or With Risk of COVID-19 in China
- ClinicalTrials.gov ID
- NCT04279899
- Acronym / sponsor ID
- CHFudanU_NNICU14
- Conditions
- Neonatal Infection, Perinatal Problems, Infectious Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- The neonates with COVID-19,or neonates born by infected mothers
Key exclusion criteria (1 listed)
- The neonates with major anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The death of newborns with COVID-19
Time frame: 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
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.
4 secondary outcomes
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 small for gestational age newborns in the neonates born to mothers with COVID-19
Time frame: at birth
The preterm delivery of neonates born to mothers with COVID-19
Time frame: at birth
The disease severity of neonates with COVID-19
Time frame: through study completion, estimated an average of 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 32699166Xiao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Infection and Perinatal Problems, run by Children's Hospital of Fudan University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The death of newborns with COVID-19 (time frame: The date of discharge，an average of 4 weeks after the admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2023.