Newborn InfantGENS2-VIENCT07329192
Study on How Parents' Anticipated Choice of a Doctor at the Maternity Hospital Influences the Newborn's First Post-discharge Consultation
An observational study of Newborn Infant and Newborn, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Newborn Infant, Newborn
- What is being tested?
- Advance Selection of a General Practitioner
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2026to 2 Mar 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Newborn Infant, Newborn
- Being tested
- Advance Selection of a General Practitioner
- Keywords
- infant, newborn, postnatal care (MeSH), general practitioner, physician, primary care, pediatric primary care, Post-discharge Follow-up, Health Services Accessibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Selection of a General PractitionerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| newborn | newborn Receives: Other: Advance Selection of a General Practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 1 month
Secondary outcomes (4)
Sociodemographic data of the parents' choice of physician for the newborn's first consultation
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.
Measured: at day 0
Questions regarding the first post-hospitalization consultation
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.
Measured: at maternity (assessed up to day 7)
Concordance between the physician designated in maternity and the physician who performed the consultation
Comparison between the physician chosen by parents before hospital discharge and the physician who actually performed the newborn's first medical examination.
Measured: at 1 month
Factors associated with delayed completion of the newborn's first consultation
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.
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start13 Jan 2026
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn InfantStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marion BATHANY, MD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329192
- Sponsor's protocol ID
- 2025/0045
- Acronym
- GENS2-VIE
- Status last verified
- Mar 2026
- First submitted
- 8 Dec 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ?
- ClinicalTrials.gov ID
- NCT07329192
- Acronym / sponsor ID
- GENS2-VIE / 2025/0045
- Conditions
- Newborn Infant, Newborn
- Keywords
- infant, newborn, postnatal care (MeSH), general practitioner, physician, primary care, pediatric primary care, Post-discharge Follow-up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 9 Jan 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| newborn | – | Other: Advance Selection of a General Practitionernewborn |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Selection of a General PractitionerThis 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. | Other | newborn |
Primary outcome
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.
4 secondary outcomes
Sociodemographic data of the parents' choice of physician for the newborn's first consultation
Time frame: at day 0
Questions regarding the first post-hospitalization consultation
Time frame: 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
Factors associated with delayed completion of the newborn's first consultation
Time frame: at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Marion BATHANY, MD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Infant and Newborn, run by Centre Hospitalier Sud Francilien at 1 site in 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Timely completion of the newborn's first post-discharge medical examination (time frame: at 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 19 Mar 2026.