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Study on How Parents' Anticipated Choice of a Doctor at the Maternity Hospital Influences the Newborn's First Post-discharge Consultation

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 ?

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07329192
Acronym
GENS2-VIE
Enrollment
120
Registered
2026-01-09
Start date
2026-01-13
Completion date
2026-03-02
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newborn, Newborn Infant

Keywords

infant, newborn, postnatal care (MeSH), general practitioner, physician, primary care, pediatric primary care, Post-discharge Follow-up, Health Services Accessibility

Brief summary

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.

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.

Interventions

OTHERAdvance Selection of a General Practitioner

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.

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Timely completion of the newborn's first post-discharge medical examinationat 1 monthAssessment 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.

Secondary

MeasureTime frameDescription
Sociodemographic data of the parents' choice of physician for the newborn's first consultationat day 0Assessment 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.
Questions regarding the first post-hospitalization consultationat 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.
Concordance between the physician designated in maternity and the physician who performed the consultationat 1 monthComparison between the physician chosen by parents before hospital discharge and the physician who actually performed the newborn's first medical examination.
Factors associated with delayed completion of the newborn's first consultationat 1 monthIdentification 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMarion BATHANY, MD

Centre Hospitalier Sud Francilien

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026