- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07329192
Study on How Parents' Anticipated Choice of a Doctor at the Maternity Hospital Influences the Newborn's First Post-discharge Consultation (GENS2-VIE)
First Required Medical Examination of the Newborn After Discharge From the Maternity Hospital: Does the Choice of a General Practitioner Facilitate Its Completion Within the Recommended Timeframe ?
The goal of this observational study is to determine whether, in a population of well-informed parents, choosing a general practitioner at the maternity hospital facilitates the completion of the newborn's first required medical examination within the second week of life.
The main question it aims to answer is: Does selecting a general practitioner before leaving the maternity hospital allow the newborn's first medical examination to be completed within the recommended period?
Participants will be asked to complete an initial questionnaire, which will be given to them before leaving the maternity hospital, and then a second questionnaire by telephone one month later.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For eligible newborns, an information sheet will be provided to the parents or legal guardians.
Parents or legal guardians who have been informed of the study and do not object to their child's participation will receive a questionnaire between the second postnatal day (D2) and discharge from the maternity ward.
Each completed questionnaire will be collected prior to discharge. The research team will then contact the parents by telephone on day 30 (±3 days) to administer the second questionnaire and record their responses.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
France
-
Corbeil-Essonnes, France, France, 91100
- Centre Hospitalier Sud Francilien
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Term newborn ≥ 37 weeks of gestation
- Birth weight > 3000 g
- Growth > 5th percentile according to Fenton curves
- No diagnosed or suspected pathology during antenatal care or the maternity stay
- No postnatal complications requiring temporary hospitalization in the neonatal unit or kangaroo care unit
Exclusion Criteria:
- Pathology diagnosed or suspected in the newborn during the maternity hospital stay.
- Requirement for temporary hospitalization in a neonatal unit or kangaroo care unit, including but not limited to: neonatal jaundice, abnormal oxygenation or laboratory findings, suspected early-onset bacterial infection, transient respiratory distress requiring more than 2 hours of non-invasive ventilation at birth, monitoring of mother-infant bonding, or maternal treatments during pregnancy necessitating clinical monitoring.
- Language barrier in both parents.
- Parents (legal guardians) informed of the study and having declined participation for themselves and their child.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
newborn
|
This exposure refers to parents selecting a general practitioner for their newborn before discharge from the maternity hospital. It represents a routine-care organizational choice that may influence whether the first post-discharge medical examination is completed within the recommended period. No study-specific procedures or treatments are administered. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timely completion of the newborn's first post-discharge medical examination
Time Frame: at 1 month
|
Assessment of whether the newborn's first medical examination after discharge from the maternity hospital is performed within the recommended period (second week of life, between day 8 and day 15). The outcome is measured as a binary variable: completed within the recommended period / not completed within the recommended period. |
at 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic data of the parents' choice of physician for the newborn's first consultation
Time Frame: at day 0
|
Assessment of parental (sociodemographic, organizational, informational) and neonatal (clinical, perinatal) characteristics associated with the selection of the physician designated to perform the newborn's first post-discharge consultation.
|
at day 0
|
|
Questions regarding the first post-hospitalization consultation
Time Frame: at maternity (assessed up to day 7)
|
Evaluation of the information received by parents and their level of knowledge regarding the purpose, timing, and importance of the newborn's first post-discharge consultation, including awareness of recommended guidelines.
|
at maternity (assessed up to day 7)
|
|
Concordance between the physician designated in maternity and the physician who performed the consultation
Time Frame: at 1 month
|
Comparison between the physician chosen by parents before hospital discharge and the physician who actually performed the newborn's first medical examination.
|
at 1 month
|
|
Factors associated with delayed completion of the newborn's first consultation
Time Frame: at 1 month
|
Identification of parental, organizational, and neonatal factors associated with completion of the first consultation after the recommended period. Outcome measured as timely vs. delayed, with analysis of associated covariates. |
at 1 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marion BATHANY, MD, Centre Hospitalier Sud Francilien
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2025/0045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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