Family-centered Round in Neonatology

Prematurity Clinical Trial

— VINCI  

Official title:

Family-centered Round in Neonatal Units : Process Development and Implementation Using the Intervention Mapping

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04852094
• Other study ID #: VINCI
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2021
• Source: University Hospital, Brest
• Contact: Jacques Sizun, MD
• Phone: +33561776280
• Email: sizun.j[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Parents Group:

Inclusion Criteria:

• French speaking

• voluntary to participate

• parents of an hospitalized newborn

Exclusion Criteria:

• not fluent in French speaking

• mental health problems

Professional group:

• any staff member

• voluntary to participate

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

Intervention

Other:
• Qualitative focus group
A qualitative focus group is performed with staff members and parents of hospitalised newborns in a NICU during Family-centered rounds management. The transcribed interviews are analyzed with qualitative content analysis in order to illuminate the experience, feelings and thoughts arisen among the staff members and the parents.

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experience of participating to a Family-Centered Care (FCR)	Qualitative focus group interview performed at one occasion where the parent describes the experience of the FCR	1 day during the last week of their newborn 'hospitalisation
Secondary	Experience of staff members in participating to a (FCR)	Qualitative focus group interview performed at one occasion where the staff members describes the experience of the FCR	1 day after 3 months of FCR experience