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

NCT05079178 | Completed

• 1 other identifier: 7863
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Keywords

COVID-19; SARS-COV-2; Newborns of COVID-19 mothers; COVID-19 Pandemic; COVID-19 Virus Disease

Outcome Measures

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

  Files analysed retrospectively from March 01, 2020 to Jun 30, 2020 will be examined]

Eligibility Criteria

• Age: 1 Day - 1 Year
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns born between March 1 and June 30, 2020 to COVID 19 from positive mothers in Strasbourg University Hospital or Mulhouse Hospital.

You may qualify if:

• 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

You may not qualify if:

• \- Parents' opposition to the analysis of hospitalization data for children contained in the medical file

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 15, 2021
• Study Start: June 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 18, 2021

Record last verified: 2021-10

Locations

FR (1)