Hospitalizations in Neonatal Period and Early Discharge o... | NCT05550272

Studies
Hospitalizations in Neonatal Period and Early Discharge of Maternity

NCT05550272

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Sep 23, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Hospitalization
Neonatal Period
Early Maternity Discharge
Risk Factor Readmission

Interventions

Not provided

Countries

Not provided

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

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2022Estimated

Primary Completion Date

Nov 2022Estimated

Completion Date

Feb 2023Estimated

First Submitted Date

Sep 19, 2022

First Submission Date that Met QC Criteria

Sep 19, 2022

First Posted Date

Sep 22, 2022Actual

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

Sep 22, 2022

Last Update Posted Date

Sep 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jourdan Laurélia, Principal investigator, Central Hospital, Nancy, FrancePrincipal Investigator

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

in the past 2 decades the number of early discharge of maternity is increasing. The aim of this study is to observe if an early maternity discharge increase the rate of hospitalization during the neonatal period.

All infants with maximum 28 days old who are hospitalized at the Hospital center of Nancy: through emergency unit of children's hospital or maternity, through intensive care unit of children's hospital.

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

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Age at maternity discharge	age in hours at the discharge of maternity	1 month

Secondary Outcomes

Measure	Description	Time Frame
Etiology of hospitalization	Description of the cause of the hospitalization	1 month
Jaundice risk factor	different risk factor of jaundice, jaundice and phototherapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

infants hospitalized maximum at the aged of 28 days (day 28 included)
infants already discharged from maternity
infants hospitalized in Hospital Center NANCY: at Children's
informed by the study, parents did not refused to participate to the study

Exclusion Criteria:

more than 28 days old
infants transferred from maternity without discharge at home.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

28 Days

Standard Ages

Child

Study Population

hospitalized infants less than 28 days old at CHU Nancy hospital through the emergency service of children's hospital, through intensive care unit or through emergency unit of the maternity regional of Nancy

Sampling Method

Non-Probability Sample