Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, 91100
NCT Number: NCT07329192
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.
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Observational
Corbeil-Essonnes, France, 91100
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Centre Hospitalier Sud Francilien
Other
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 ?
Acronym: GENS2-VIE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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