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Fever Infants and Therapeutic Education in Emergency Department (D-FI-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706599
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
To evaluate the effect of a therapeutic education session on fever versus a control education session on household accidents on the behavior and knowledge of families concerning the management of infant fever between day 4 and day 7 after the intervention

Condition or disease Intervention/treatment Phase
Fever Behavioral: Therapeutic education on fever Behavioral: Therapeutic education on household accidents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fever Infants and Therapeutic Education in Emergency Department
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : February 26, 2021
Estimated Study Completion Date : September 25, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Fever therapeutic education session
Therapeutic education session on fever
Behavioral: Therapeutic education on fever
Session for therapeutique education on fever

Placebo Comparator: Control therapeutic education session
Control therapeutic education session (on household accidents)
Behavioral: Therapeutic education on household accidents
Session for therapeutic education on household accidents




Primary Outcome Measures :
  1. Behavior and knowledge score of families obtain through answering D-FI (Decrease Fever Infants) survey [ Time Frame: Day 4 ]
    score D-FI survey :D-FI survey is a scale measuring behavior and knowledge of families on fever. Range from 0 (low score) to 10 (high score=better knowledge and behavior).


Secondary Outcome Measures :
  1. Behavior and knowledge of families obtain through answering D-FI (Decrease Fever Infants) survey [ Time Frame: 6 months ]
    score D-FI survey :D-FI survey is a scale measuring behavior and knowledge of families on fever. Range from 0 (low score) to 10 (high score=better knowledge and behavior).

  2. Number of medical consultation unplanned [ Time Frame: 6 months ]
  3. Number of pediatric emergency consultation [ Time Frame: 6 months ]
  4. Number of suboptimal care and severe bacterial infection [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Francophone family who consults for a febrile illness of their child (defined by a t °> 38 °) aged from 3 months to 2 years at the time of passage to pediatric emergencies Presence of at least one parent or guardian of the child

Exclusion Criteria:

  • Presence of chronic pathology Family already included in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706599


Contacts
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Contact: François Angoulvant, MD, PhD 0033171396968 francois.angoulvant@aphp.fr
Contact: Anne Rouault, PD 0033140032000 anne.rouault@aphp.fr

Locations
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France
Necker Hospital Recruiting
Paris, France, 75015
Contact: François Angoulvant, MD, PhD    0033171396968    francois.angoulvant@aphp.fr   
Contact: Anne Rouault, PD    0033140032000    anne.rouault@aphp.fr   
Principal Investigator: François Angoulvant, MD, PhD         
Sub-Investigator: Anne Rouault         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: François Angoulvant, MD, PhD APHP
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03706599    
Other Study ID Numbers: K170306J / AOR12065
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Fever
Disease Attributes
Pathologic Processes
Body Temperature Changes