NCT07329192

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

December 8, 2025

Last Update Submit

March 18, 2026

Conditions

Keywords

infantnewbornpostnatal care (MeSH)general practitionerphysicianprimary carepediatric primary carePost-discharge Follow-upHealth Services Accessibility

Outcome Measures

Primary Outcomes (1)

  • Timely completion of the newborn's first post-discharge medical examination

    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 Outcomes (4)

  • Sociodemographic data of the parents' choice of physician for the newborn's first consultation

    at day 0

  • Questions regarding the first post-hospitalization consultation

    at maternity (assessed up to day 7)

  • Concordance between the physician designated in maternity and the physician who performed the consultation

    at 1 month

  • Factors associated with delayed completion of the newborn's first consultation

    at 1 month

Study Arms (1)

newborn

newborn

Other: Advance Selection of a General Practitioner

Interventions

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.

newborn

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy term newborns recruited prior to discharge from the maternity hospital. Included infants are healthy term newborns (≥37 weeks of gestation, birth weight \>3000 g) with no antenatal or postnatal pathology requiring hospitalization. Parents or legal guardians must understand the study information and not object to participation.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100, France

Location

Study Officials

  • Marion BATHANY, MD

    Centre Hospitalier Sud Francilien

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 9, 2026

Study Start

January 13, 2026

Primary Completion

March 2, 2026

Study Completion

March 2, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations