Preterm BirthPrémaSoinNCT03394443
Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ?
An observational study of Preterm Birth, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Semi-structured interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2017to Apr 2018
- 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 Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Parents of a premature new-born baby (< 37 SA)
Who may be able to join
- Parents (father or mother ) of a premature new-born baby (< 37 SA) hospitalised in Besancon University Hospital at birth.
Who cannot join
- Parents < 18 years old
- Refusing to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon
Hana Najid, Int, hana.najid@hotmail.fr
About this study
Official title: Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? A Qualitative Study in Besancon University Hospital.
This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.
Read the detailed description
- From parents collected during semi-structured interviews.
- To highlight the social, environmental and economic difficulties that parents have encountered in the context of the premature birth of their child (before birth, during hospitalization and return home).
- Determine the possible help they need in the psychosocial and environmental field.
- Difficulties of the parents we expected:
- Pre-existing child birth: poor socio-economic environment, unstable social, family and / or occupational status, poorly followed pregnancy, etc.
- After the birth: professional break-up, custody of other children of the siblings, balance of the couple, financial loss, isolation, transportation problems to get to the hospital, etc.
- Needs we expected :
- Before birth: measures to prevent prematurity, social and/or psychological support, information, etc.
- After the birth: support of the entourage, interview with a social worker, help to come in hospital, help to live near the hospital, parental leave, project and long-term support, doctor referred, relationship with professionals in ambulatory (psychologist, Infant and Maternal Protection ...), preparation of the arrival of the child at home +/- home improvement, etc.
- Conditions
- Preterm Birth
- Being tested
- Semi-structured interviews
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interviewsBehavioural
Semi-structured interviews of the parents of preterm infants. 3 weeks after their child has left hospital. They will be made either at the University Hospital of Besançon. They will take place in a dedicated hospital ward to ensure the confidentiality of the statements made between the investigator and the parent.
They will follow a predefined questionnaire. They will be fully recorded on a dictaphone with note taking during the interview by the investigator and will be transcribed in writing anonymously and confidentially on Word.
The content of the interviews will be analyzed:
- As a first step, it will be a vertical analysis of the thematization of each interview
- Then, in a second step, a transversal analysis between the contents of the different interviews.
What is being measured
The primary outcome is the main question the study is designed to answer.
Social, environmental and economic difficulties encountered by parents
Qualitative analysis of semi-structured interviews
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start28 Dec 2017
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394443
- Sponsor's protocol ID
- P/2017/347
- Acronym
- PrémaSoin
- Status last verified
- Jan 2018
- First submitted
- 28 Dec 2017
- Last updated
- 9 Jan 2018
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? A Qualitative Study in Besancon University Hospital.
- ClinicalTrials.gov ID
- NCT03394443
- Acronym / sponsor ID
- PrémaSoin / P/2017/347
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 9 Jan 2018 (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.
This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.
Detailed description
- From parents collected during semi-structured interviews.
- To highlight the social, environmental and economic difficulties that parents have encountered in the context of the premature birth of their child (before birth, during hospitalization and return home).
- Determine the possible help they need in the psychosocial and environmental field.
- Difficulties of the parents we expected:
- Pre-existing child birth: poor socio-economic environment, unstable social, family and / or occupational status, poorly followed pregnancy, etc.
- After the birth: professional break-up, custody of other children of the siblings, balance of the couple, financial loss, isolation, transportation problems to get to the hospital, etc.
- Needs we expected :
- Before birth: measures to prevent prematurity, social and/or psychological support, information, etc.
- After the birth: support of the entourage, interview with a social worker, help to come in hospital, help to live near the hospital, parental leave, project and long-term support, doctor referred, relationship with professionals in ambulatory (psychologist, Infant and Maternal Protection ...), preparation of the arrival of the child at home +/- home improvement, etc.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Parents of a premature new-born baby (< 37 SA)
Key inclusion criteria (1 listed)
- Parents (father or mother ) of a premature new-born baby (< 37 SA) hospitalised in Besancon University Hospital at birth.
Key exclusion criteria (2 listed)
- Parents < 18 years old
- Refusing to participate
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 |
|---|---|---|
| Semi-structured interviewsSemi-structured interviews of the parents of preterm infants. 3 weeks after their child has left hospital. They will be made either at the University Hospital of Besançon. They will take place in a dedicated hospital ward to ensure the confidentiality of the statements made between the investigator and the parent. They will follow a predefined questionnaire. They will be fully recorded on a dictaphone with note taking during the interview by the investigator and will be transcribed in writing anonymously and confidentially on Word. The content of the interviews will be analyzed: * As a first step, it will be a vertical analysis of the thematization of each interview * Then, in a second step, a transversal analysis between the contents of the different interviews. | Behavioural | – |
Primary outcome
Social, environmental and economic difficulties encountered by parents
Time frame: Month 1
Qualitative analysis of semi-structured interviews
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- 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.
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 Preterm Birth, run by Centre Hospitalier Universitaire de Besancon 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NAJID Hana (0033381219163, hana.najid@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social, environmental and economic difficulties encountered by parents (time frame: Month 1). 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 9 Jan 2018.