NCT04925401

Brief Summary

The purpose of this study is to evaluate the effect of an information brochure on parent / legal guardians' knowledge of what to do about their child's febrile episode after a pediatric emergency department visit. Single-center randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

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

May 27, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2022

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

12 months

First QC Date

May 27, 2021

Last Update Submit

November 17, 2025

Conditions

Keywords

Febrile episodepediatricpediatric emergency departmenttherapeutic education

Outcome Measures

Primary Outcomes (1)

  • Number of participants with correct answer to question about management of a paediatric febrile episode.

    Number of correct answers to question n°7 (what to do during a febrile episode) of the questionnaire

    1 day

Secondary Outcomes (9)

  • Number of participants with correct answer to question n°1 about knowledge about paediatric febrile episode

    1 day

  • Number of participants with correct answer to question n°2 about knowledge's about paediatric febrile episode

    1 day

  • Number of participants with correct answer to question n°3 about knowledge's about paediatric febrile episode

    1 day

  • Number of participants with correct answer to question n°4 about knowledge's about paediatric febrile episode

    1 day

  • Number of participants with correct answer to question n°5 about knowledge's about paediatric febrile episode

    1 day

  • +4 more secondary outcomes

Study Arms (2)

Information brochure Arm

EXPERIMENTAL

The experimental group will receive an information brochure on fever in children and how to deal with a febrile episode and usual medical management.

Behavioral: The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.

Habitual care

NO INTERVENTION

The control group will receive the usual medical management

Interventions

An information brochure on fever in children and how to deal with a paediatric febrile episode and usual medical management.

Information brochure Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be of legal age
  • Be the parent/legal guardian of a child aged between 3 months and 15 years,
  • A child with a fever \> 38°celsus on arrival at the emergency room (measured by electronic thermometer rectally for children under 2 years of age or axillary/oral for children over 2 years of age),
  • Severity of care rating by the IOA grade 4 (non-emergency care)
  • Parent affiliated to a social security system or entitled to it
  • Parent under "AME" French social security system
  • Parent informed and having signed the consent

You may not qualify if:

  • Parent/legal guardian who does not speak or read French,
  • Child with a pathology that does not allow for rectal temperature taking
  • Parent/legal guardian with a visual impairment that prevents reading the information note and/or the information brochure.
  • Parent / legal guardian under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

APHP Assistance Publique des Hôpitaux de Paris

Paris, 75015, France

Location

Related Publications (14)

  • Schmitt BD. Fever phobia: misconceptions of parents about fevers. Am J Dis Child. 1980 Feb;134(2):176-81.

    PMID: 7352443BACKGROUND
  • Poirier MP, Davis PH, Gonzalez-del Rey JA, Monroe KW. Pediatric emergency department nurses' perspectives on fever in children. Pediatr Emerg Care. 2000 Feb;16(1):9-12. doi: 10.1097/00006565-200002000-00003.

    PMID: 10698135BACKGROUND
  • Burokiene S, Kairiene I, Stricka M, Labanauskas L, Cerkauskiene R, Raistenskis J, Burokaite E, Usonis V. Unscheduled return visits to a pediatric emergency department. Medicina (Kaunas). 2017;53(1):66-71. doi: 10.1016/j.medici.2017.01.003. Epub 2017 Jan 31.

    PMID: 28233682BACKGROUND
  • Bereznicki BJ, Tucker MG, Beggs SA, Zosky GR, Bereznicki LR. Emergency department presentations of febrile children to an Australian public hospital. J Paediatr Child Health. 2018 Dec;54(12):1308-1313. doi: 10.1111/jpc.14071. Epub 2018 Jun 6.

    PMID: 29874409BACKGROUND
  • Enarson MC, Ali S, Vandermeer B, Wright RB, Klassen TP, Spiers JA. Beliefs and expectations of Canadian parents who bring febrile children for medical care. Pediatrics. 2012 Oct;130(4):e905-12. doi: 10.1542/peds.2011-2140. Epub 2012 Sep 10.

    PMID: 22966028BACKGROUND
  • Betz MG, Grunfeld AF. 'Fever phobia' in the emergency department: a survey of children's caregivers. Eur J Emerg Med. 2006 Jun;13(3):129-33. doi: 10.1097/01.mej.0000194401.15335.c7.

    PMID: 16679875BACKGROUND
  • Morrison AK, Chanmugathas R, Schapira MM, Gorelick MH, Hoffmann RG, Brousseau DC. Caregiver low health literacy and nonurgent use of the pediatric emergency department for febrile illness. Acad Pediatr. 2014 Sep-Oct;14(5):505-9. doi: 10.1016/j.acap.2014.05.001. Epub 2014 Jun 16.

    PMID: 24942934BACKGROUND
  • Walsh A, Edwards H. Management of childhood fever by parents: literature review. J Adv Nurs. 2006 Apr;54(2):217-27. doi: 10.1111/j.1365-2648.2006.03802.x.

    PMID: 16553708BACKGROUND
  • Walsh A, Edwards H, Fraser J. Parents' childhood fever management: community survey and instrument development. J Adv Nurs. 2008 Aug;63(4):376-88. doi: 10.1111/j.1365-2648.2008.04721.x.

    PMID: 18727765BACKGROUND
  • Peetoom KK, Smits JJ, Ploum LJ, Verbakel JY, Dinant GJ, Cals JW. Does well-child care education improve consultations and medication management for childhood fever and common infections? A systematic review. Arch Dis Child. 2017 Mar;102(3):261-267. doi: 10.1136/archdischild-2016-311042. Epub 2016 Jul 18.

    PMID: 27432451BACKGROUND
  • Considine J, Brennan D. Effect of an evidence-based education programme on ED discharge advice for febrile children. J Clin Nurs. 2007 Sep;16(9):1687-94. doi: 10.1111/j.1365-2702.2006.01716.x.

    PMID: 17727587BACKGROUND
  • Monsma J, Richerson J, Sloand E. Empowering parents for evidence-based fever management: An integrative review. J Am Assoc Nurse Pract. 2015 Apr;27(4):222-9. doi: 10.1002/2327-6924.12152. Epub 2014 Jul 25.

    PMID: 25066313BACKGROUND
  • Broome ME, Dokken DL, Broome CD, Woodring B, Stegelman MF. A study of parent/grandparent education for managing a febrile illness using the CALM approach. J Pediatr Health Care. 2003 Jul-Aug;17(4):176-83. doi: 10.1067/mph.2003.4.

    PMID: 12847427BACKGROUND
  • Baker MD, Monroe KW, King WD, Sorrentino A, Glaeser PW. Effectiveness of fever education in a pediatric emergency department. Pediatr Emerg Care. 2009 Sep;25(9):565-8. doi: 10.1097/PEC.0b013e3181b4f64e.

    PMID: 19755888BACKGROUND

MeSH Terms

Conditions

Fever

Interventions

Health

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

  • Hélène CHAPPUY, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2021

First Posted

June 14, 2021

Study Start

November 2, 2021

Primary Completion

October 21, 2022

Study Completion

October 21, 2022

Last Updated

November 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations