NCT04852094

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

April 11, 2021

Last Update Submit

April 15, 2021

Conditions

Keywords

NewbornPretermmedical roundfamily-centered careNICU

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Experience of staff members in participating to a (FCR)

    1 day after 3 months of FCR experience

Study Arms (2)

Parents

parents of hospitalized children, speaking and understanding enough French, not presenting psychiatric disorders, voluntary to participate in focus groups

Other: Qualitative focus group

Professionals

Nurses, assistant nurses, psychologist, physiotherapist, physicians, residents and fellows

Other: Qualitative focus group

Interventions

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.

ParentsProfessionals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parents group: age, parity, education and income level Staff group: age, gender, years of experience in the NICU, profession

You may qualify if:

  • French speaking
  • voluntary to participate
  • parents of an hospitalized newborn

You may not qualify if:

  • not fluent in French speaking
  • mental health problems
  • Professional group:
  • any staff member
  • voluntary to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Jacques Sizun

    University Hospital, Brest

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Sizun, MD

CONTACT

Jean-Michel Roue, MD, Phd

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2021

First Posted

April 21, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 21, 2021

Record last verified: 2021-04

Locations