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

Preterm Birth Clinical Trial

— PrémaSoin  

Official title:

Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ? A Qualitative Study in Besancon University Hospital.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03394443
• Other study ID #: P/2017/347
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2017
• Last updated: January 8, 2018
• Start date: December 28, 2017
• Est. completion date: April 2018

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: NAJID Hana
• Phone: 0033381219163
• Email: hana.najid[@]hotmail.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Social, environmental and economic difficulties encountered by parents	Qualitative analysis of semi-structured interviews	Month 1