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NCT05079178 Clinical Trial

Newborns in Level III Services in Alsace From Mothers With COVID-19

COVID-19 Clinical Trial

— COVID-Néo  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05079178
Other study ID # 7863
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date October 31, 2021

Study information
Verified date October 2021
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A to 1 Year
Eligibility Inclusion criteria: - 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 Exclusion criteria: - Parents' opposition to the analysis of hospitalization data for children contained in the medical file

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Service de Médecine et Réanimation du Nouveau-né - Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Files analysed retrospectively from March 01, 2020 to Jun 30, 2020 will be examined]
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