NCT04648605

Brief Summary

The elements that promote the development of post-traumatic stress in parents following hospitalization in pediatric resuscitation and thus the options for improving initial care at the time of hospitalization are unknown. It is therefore important to describe the prevalence of post-traumatic stress disorder with current pediatric resuscitation management data, but also to possibly describe the factors associated with it in order to optimize initial management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 26, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2021

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

November 23, 2020

Last Update Submit

November 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of post-traumatic stress disorder among parents of newborns, infants and children who have been hospitalized in a paediatric resuscitation unit.

    Parents will complete Post-traumatic stress disorder Checklist. We will consider subjects with a score above 44 to be clinically affected by post-traumatic stress disorder.

    Between one and 6 months after hospitalization.

Study Arms (1)

Questionary

EXPERIMENTAL

Questionary for all parents

Other: Post traumatic stress disorder questionnaire

Interventions

Parents of hospitalized children in pediatric resuscitation carry out a validated questionnaire that validates the post-traumatic stress level by a score.

Questionary

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \- All parents of children aged 0 to 18 who have been admitted in paediatric resuscitation unit.

You may not qualify if:

  • Holders of parental authority who cannot answer the questionnaire because they do not speak French.
  • Opposition of one of the two holders of parental authority
  • Minor parental authority holders
  • Holders of parental authority under safeguarding of justice or guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

Study Officials

  • Sophie BREINIG, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2020

First Posted

December 1, 2020

Study Start

January 26, 2021

Primary Completion

March 9, 2021

Study Completion

March 9, 2021

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations