Newborns in Level III Services in Alsace From Mothers Wit... | NCT05079178

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

NCT05079178

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Nov 18, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

COVID-19

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Oct 31, 2021Actual

Completion Date

Oct 31, 2021Actual

First Submitted Date

Oct 14, 2021

First Submission Date that Met QC Criteria

Oct 14, 2021

First Posted Date

Oct 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2021

Last Update Posted Date

Nov 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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]

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

1 Year

Standard Ages

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Médecine et Réanimation du Nouveau-né - Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided