COVID-19CoronababiesNCT05430594
This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development.
An observational study of COVID-19, run by Semmelweis University at 1 site in Hungary.
Trial summary
This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too. Read more about this study
- Who is it for?
- Ages 12 to 16 monthsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- How many people
- 130 participants
- Where
- 1 siteHungary
- Study dates
- 2 Jan 2022to 30 Jun 2024
- 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 12 to 16 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Firstly we examine the infants at 1 year old. We do control examination if it is necessary or give advice. We did a next examination at 2 years old in every cases.
Who may be able to join
- postitive maternal COVID test during the birth
- the newborn was cared at the Semmelweis University after birth
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Semmelweis University, Department of Obstetrics and Gynecology
Budapest, 1078
Fanni Toth, Dr, toth.fanni2@gamil.com
About this study
Official title: Long-term Followup of Children Was Born From COVID Positive Mother During Birth
This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too.
- Conditions
- COVID-19
- Keywords
- followup, longterm outcome, child development, maternal COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental outcome
Measured: 2 years old
Secondary outcomes (5)
Neurodevelopmental outcome
Measured: 1 year old
Phsycosomatic outcome
Measured: 1 and 2 years old
Regulation disorders
Measured: 1 and 2 years old
Feeding
Measured: 1 and 2 years old
Maternal mental status
Measured: 1 and 2 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start2 Jan 2022
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Semmelweis 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430594
- Sponsor's protocol ID
- SE RKEB: 14/2022.
- Acronym
- Coronababies
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Followup of Children Was Born From COVID Positive Mother During Birth
- ClinicalTrials.gov ID
- NCT05430594
- Acronym / sponsor ID
- Coronababies / SE RKEB: 14/2022.
- Conditions
- COVID-19
- Keywords
- followup, longterm outcome, child development, maternal COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 24 Jun 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.
This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 16 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Firstly we examine the infants at 1 year old. We do control examination if it is necessary or give advice. We did a next examination at 2 years old in every cases.
Key inclusion criteria (2 listed)
- postitive maternal COVID test during the birth
- the newborn was cared at the Semmelweis University after birth
Key exclusion criteria (0 listed)
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
Neurodevelopmental outcome
Time frame: 2 years old
5 secondary outcomes
Neurodevelopmental outcome
Time frame: 1 year old
Phsycosomatic outcome
Time frame: 1 and 2 years old
Regulation disorders
Time frame: 1 and 2 years old
Feeding
Time frame: 1 and 2 years old
Maternal mental status
Time frame: 1 and 2 years old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Individual participant dataSharing planned: No
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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.
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 COVID-19, run by Semmelweis University at 1 site in Hungary.
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 24 Jun 2022. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanni Toth, Dr (+36306924507, toth.fanni2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental outcome (time frame: 2 years old). 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 24 Jun 2022.