SARS-CoV2 InfectionNCT05379452
Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection in Shanghai
An observational study of SARS-CoV2 Infection and Neonatal Infection, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Since March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- SARS-CoV2 Infection, Neonatal Infection, Outcomes
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2022to 1 Jan 2023
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates born to mothers with SARS-CoV-2 infections will be recruited from all the designated hospital during the outbreak of Omicron in Shanghai.
Who may be able to join
- Neonates born to mothers with SARS-CoV-2 infections.
Who cannot join
- Parents who rejected to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection During the Outbreak of Omicron in Shanghai: a Cohort Study.
Since March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection.
- Conditions
- SARS-CoV2 Infection, Neonatal Infection, Outcomes
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
The death of newborns
Measured: The date of discharge，an average of 4 weeks after the admission
Secondary outcomes (5)
The malformation rate of neonates born to mothers with SARS-CoV-2 infections
Measured: Birth
The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections
Measured: Birth
The brain injury rate of neonates born to mothers with SARS-CoV-2 infections
Measured: within 7days after the admission
The development delay rate of neonates born to mothers with SARS-CoV-2 infections
Measured: within 1 year after the admission
The Chinese standardized Denver Developmental Screening Test (DDST) in neonates born to mothers with SARS-CoV-2 infections
Measured: Infants ( ≥35 weeks）are at 1 year after birth;Infants（< 35weeks） are at a corrected age of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start1 Mar 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Why it stopped: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 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
- NCT05379452
- Sponsor's protocol ID
- CHFudanU_COVID19-2
- Status last verified
- Dec 2023
- First submitted
- 16 May 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Neonates Born to Mothers With SARS-CoV-2 Infection During the Outbreak of Omicron in Shanghai: a Cohort Study.
- ClinicalTrials.gov ID
- NCT05379452
- Acronym / sponsor ID
- CHFudanU_COVID19-2
- Conditions
- SARS-CoV2 Infection, Neonatal Infection, Outcomes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 18 May 2022 (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 March 2022, there are an outbreak of SARS-CoV-2 infection (Omicron) in Shanghai. This cohort study aims to analysis the clinical outcomes of neonates born to mothers with SARS-CoV-2 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates born to mothers with SARS-CoV-2 infections will be recruited from all the designated hospital during the outbreak of Omicron in Shanghai.
Key inclusion criteria (1 listed)
- Neonates born to mothers with SARS-CoV-2 infections.
Key exclusion criteria (1 listed)
- Parents who rejected to participate in this study.
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
Time frame: The date of discharge，an average of 4 weeks after the admission
5 secondary outcomes
The malformation rate of neonates born to mothers with SARS-CoV-2 infections
Time frame: Birth
The preterm delivery rate of neonates born to mothers with SARS-CoV-2 infections
Time frame: Birth
The brain injury rate of neonates born to mothers with SARS-CoV-2 infections
Time frame: within 7days after the admission
The development delay rate of neonates born to mothers with SARS-CoV-2 infections
Time frame: within 1 year after the admission
The Chinese standardized Denver Developmental Screening Test (DDST) in neonates born to mothers with SARS-CoV-2 infections
Time frame: Infants ( ≥35 weeks）are at 1 year after birth;Infants（< 35weeks） are at a corrected age of 1 year
Results and safety
The study was stopped early (reason given: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV2 Infection and Neonatal Infection, run by Children's Hospital of Fudan University at 1 site 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: stopped early, as of the sponsor's last update on 29 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 1 site 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 was stopped early (reason given: The study was concluded as planned upon reaching its predetermined endpoint, which included the completion of data collection and achievement of the necessary sample size for statistical significance.). Results are not available in the source record.
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 (time frame: The date of discharge，an average of 4 weeks after the admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2023.