NCT05550272

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 23, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

September 19, 2022

Last Update Submit

September 22, 2022

Conditions

HospitalizationNeonatal PeriodEarly Maternity DischargeRisk Factor Readmission

Keywords

neonatalreadmissionearly discharge maternitycauses of readmission

Outcome Measures

Primary Outcomes (1)

  • Age at maternity discharge

    age in hours at the discharge of maternity

    1 month

Secondary Outcomes (5)

  • Etiology of hospitalization

    1 month

  • Jaundice risk factor

    1 month

  • Risk factor of early neonatal bacterial infection

    1 month

  • social environment at home, mother's parity

    1 month

  • pediatrics follow up

    1 month

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 19, 2022

First Posted

September 22, 2022

Study Start

September 1, 2022

Primary Completion

November 1, 2022

Study Completion

February 1, 2023

Last Updated

September 23, 2022

Record last verified: 2022-09