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Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? (PrémaSoin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03394443
Recruitment Status : Unknown
Verified January 2018 by Centre Hospitalier Universitaire de Besancon.
Recruitment status was:  Recruiting
First Posted : January 9, 2018
Last Update Posted : January 9, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.

Condition or disease Intervention/treatment
Preterm Birth Behavioral: Semi-structured interviews

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? A Qualitative Study in Besancon University Hospital.
Actual Study Start Date : December 28, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : April 2018

Intervention Details:
  • Behavioral: Semi-structured interviews

    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.

Primary Outcome Measures :
  1. Social, environmental and economic difficulties encountered by parents [ Time Frame: Month 1 ]
    Qualitative analysis of semi-structured interviews

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parents of a premature new-born baby (< 37 SA)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03394443

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Contact: NAJID Hana 0033381219163

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CHU de Besançon Recruiting
Besançon, France
Contact: Hana Najid, Int   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
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Responsible Party: Centre Hospitalier Universitaire de Besancon Identifier: NCT03394443    
Other Study ID Numbers: P/2017/347
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications