HospitalizationNCT05550272
Hospitalizations in Neonatal Period and Early Discharge of Maternity
An observational study of Hospitalization and Neonatal Period, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Hospitalization, Neonatal Period, Early Maternity Discharge
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- 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
Who may be able to join
- 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
Who cannot join
- more than 28 days old
- infants transferred from maternity without discharge at home.
About this study
Official title: Inventory of Hospitalizations in the Neonatal Period and Validation of the Early Maternity Discharge Protocol: Retrospective Observational Study
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.
- Keywords
- neonatal, readmission, early discharge maternity, causes of readmission
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at maternity discharge
age in hours at the discharge of maternity
Measured: 1 month
Secondary outcomes (5)
Etiology of hospitalization
Description of the cause of the hospitalization
Measured: 1 month
Jaundice risk factor
different risk factor of jaundice, jaundice and phototherapy
Measured: 1 month
Risk factor of early neonatal bacterial infection
mother's and newborn's risk factor to determinate follow up
Measured: 1 month
social environment at home, mother's parity
determined the environment of the newborn for a safety maternity discharge
Measured: 1 month
pediatrics follow up
the follow up set up at home by the different medical stuff (pediatrician, family doctor, midwife
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionFeb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jourdan Laurélia, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550272
- Sponsor's protocol ID
- 2022PI110
- Status last verified
- Sep 2022
- First submitted
- 19 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inventory of Hospitalizations in the Neonatal Period and Validation of the Early Maternity Discharge Protocol: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05550272
- Acronym / sponsor ID
- 2022PI110
- Keywords
- neonatal, readmission, early discharge maternity, causes of readmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- more than 28 days old
- infants transferred from maternity without discharge at home.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age at maternity discharge
Time frame: 1 month
age in hours at the discharge of maternity
5 secondary outcomes
Etiology of hospitalization
Time frame: 1 month
Jaundice risk factor
Time frame: 1 month
Risk factor of early neonatal bacterial infection
Time frame: 1 month
social environment at home, mother's parity
Time frame: 1 month
pediatrics follow up
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization and Neonatal Period, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at maternity discharge (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022.