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OpenTrials
Completed

NCT Number: NCT05079178

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.

Completed

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Key information

Age range

1 day–1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine et Réanimation du Nouveau-né - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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]

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study 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

Acronym: COVID-Néo

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 15, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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