- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394443
Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? (PrémaSoin)
January 8, 2018 updated by: Centre Hospitalier Universitaire de Besancon
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: NAJID Hana
- Phone Number: 0033381219163
- Email: hana.najid@hotmail.fr
Study Locations
-
-
-
Besançon, France
- Recruiting
- CHU de Besancon
-
Contact:
- Hana Najid, Int
- Email: hana.najid@hotmail.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 8 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Parents of a premature new-born baby (< 37 SA)
Description
Inclusion Criteria:
- Parents (father or mother ) of a premature new-born baby (< 37 SA) hospitalised in Besancon University Hospital at birth.
Exclusion Criteria:
- Parents < 18 years old
- Refusing to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Social, environmental and economic difficulties encountered by parents
Time Frame: Month 1
|
Qualitative analysis of semi-structured interviews
|
Month 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2017
Primary Completion (Anticipated)
March 1, 2018
Study Completion (Anticipated)
April 1, 2018
Study Registration Dates
First Submitted
December 28, 2017
First Submitted That Met QC Criteria
January 8, 2018
First Posted (Actual)
January 9, 2018
Study Record Updates
Last Update Posted (Actual)
January 9, 2018
Last Update Submitted That Met QC Criteria
January 8, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P/2017/347
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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