COVID-19COVID-NéoNCT05079178
Newborns in Level III Services in Alsace From Mothers With COVID-19
An observational study of COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Very little is known about the impact on the newborn of late pre-partum maternal SARS-CoV-2 infection. Care without separation of the mother and her newborn with continued breastfeeding has been advocated in France and by the WHO but is being debated in some countries. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- COVID-19
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2020to 31 Oct 2021
- 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 1 day to 1 year
- All sexes
- Child
Study population: Newborns born between March 1 and June 30, 2020 to COVID 19 from positive mothers in Strasbourg University Hospital or Mulhouse Hospital.
Who may be able to join
- Newborns born between March 1 and June 30, 2020 to COVID 19
- From positive mothers in Strasbourg University Hospital or Mulhouse Hospital.
- Parents' non-opposition to the analysis of hospitalization data for children contained in the medical file
Who cannot join
- Parents' opposition to the analysis of hospitalization data for children contained in the medical file
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine et Réanimation du Nouveau-né - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Retrospective Clinical Study of the Care and Follow-up in the First Month of Life of Newborns in Level III Services in Alsace From Mothers With COVID-19
Very little is known about the impact on the newborn of late pre-partum maternal SARS-CoV-2 infection.
Care without separation of the mother and her newborn with continued breastfeeding has been advocated in France and by the WHO but is being debated in some countries.
Assessment of the development of newborns in their first month of life with this strategy associated with close and secure follow-up.
Importance of reporting the potential benefits / risks of this treatment to guide the care of newborns in a persistent epidemic context in a particularly affected region.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Newborns of COVID-19 mothers, COVID-19 Pandemic, COVID-19 Virus Disease
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective description of the care and follow-up in the first month of life of newborns in level III services in Alsace from mothers with COVID-19
Measured: Files analysed retrospectively from March 01, 2020 to Jun 30, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jun 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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 University Hospital, Strasbourg, FranceThe 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079178
- Sponsor's protocol ID
- 7863
- Acronym
- COVID-Néo
- Status last verified
- Oct 2021
- First submitted
- 14 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Clinical Study of the Care and Follow-up in the First Month of Life of Newborns in Level III Services in Alsace From Mothers With COVID-19
- ClinicalTrials.gov ID
- NCT05079178
- Acronym / sponsor ID
- COVID-Néo / 7863
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-COV-2, Newborns of COVID-19 mothers, COVID-19 Pandemic, COVID-19 Virus Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 15 Oct 2021 (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.
Very little is known about the impact on the newborn of late pre-partum maternal SARS-CoV-2 infection.
Care without separation of the mother and her newborn with continued breastfeeding has been advocated in France and by the WHO but is being debated in some countries.
Assessment of the development of newborns in their first month of life with this strategy associated with close and secure follow-up.
Importance of reporting the potential benefits / risks of this treatment to guide the care of newborns in a persistent epidemic context in a particularly affected region.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Age groups
- Child
- Study population
- Newborns born between March 1 and June 30, 2020 to COVID 19 from positive mothers in Strasbourg University Hospital or Mulhouse Hospital.
Key inclusion criteria (3 listed)
- Newborns born between March 1 and June 30, 2020 to COVID 19
- From positive mothers in Strasbourg University Hospital or Mulhouse Hospital.
- Parents' non-opposition to the analysis of hospitalization data for children contained in the medical file
Key exclusion criteria (1 listed)
- Parents' opposition to the analysis of hospitalization data for children contained in the medical file
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
Retrospective description of the care and follow-up in the first month of life of newborns in level III services in Alsace from mothers with COVID-19
Time frame: Files analysed retrospectively from March 01, 2020 to Jun 30, 2020 will be examined]
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 18 Nov 2021.
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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 COVID-19, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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 18 Nov 2021. 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 France. 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?
Retrospective description of the care and follow-up in the first month of life of newborns in level III services in Alsace from mothers with COVID-19 (time frame: Files analysed retrospectively from March 01, 2020 to Jun 30, 2020 will be examined]). 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 18 Nov 2021.