NCT03828552

Brief Summary

Children recovered in pediatric intensive care unit (PICU) suffer from severe conditions, sometimes life-threatening. Thus, priority is given to urgent somatic care, children medicalization is strong, invasive technics have to be used, and medical monitoring is close. A stay in PICU often leaves a painful memory to the child and family, and can lead to psychological morbidity such as post-traumatic stress disease. This study aims to assess parents' experience during their child hospitalization in PICU, and the impact of this stay on the entire family in the following month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 25, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

4 months

First QC Date

January 25, 2019

Last Update Submit

September 4, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Analyse qualitatively the parents'experience during the PICU stay of their child

    Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)

    1 month

  • Assessment of the impact on the family of this PICU stay of their child

    Analysis of french written answers on a feedback form of about 10 pages (free written answers or Likert scale)

    1 month

Interventions

Parents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study. A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire. The completed questionnaire will be mailed back by the parents using the pre-stamped envelope.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parent (mother or /and father) of a recovered child in the PICU for at least 3 days, for a first stay, without limit of age, disease or admission mode.

You may qualify if:

  • Parent (mother or /and father) of a recovered child in PICU.
  • No limit of age, disease or admission mode.
  • First stay in PICU, for at least a 3 days stay.
  • Parents having been informed and having accepted the participation in the study.

You may not qualify if:

  • Death of the child during the stay in PICU or during the month following the discharge from PICU
  • Non-fluent french speakers/readers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric intensive care unit of Women-Mother-Children Hospital

Bron, 69677, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

January 25, 2019

First Posted

February 4, 2019

Study Start

March 4, 2019

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations