Fever Infants and Therapeutic Education in Emergency Department

NCT03706599 | Completed

• 1 other identifier: K170306J / AOR12065
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

• Behavior and knowledge score of families obtain through answering D-FI (Decrease Fever Infants) survey

  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).

  Day 4

Secondary Outcomes (4)

• Behavior and knowledge of families obtain through answering D-FI (Decrease Fever Infants) survey

  6 months

• Number of medical consultation unplanned

  6 months

• Number of pediatric emergency consultation

  6 months

• Number of suboptimal care and severe bacterial infection

  6 months

Study Arms (2)

Fever therapeutic education session

EXPERIMENTAL

Therapeutic education session on fever

Behavioral: Therapeutic education on fever

Control therapeutic education session

PLACEBO COMPARATOR

Control therapeutic education session (on household accidents)

Behavioral: Therapeutic education on household accidents

Interventions

Therapeutic education on fever BEHAVIORAL

Session for therapeutique education on fever

Fever therapeutic education session

Therapeutic education on household accidents BEHAVIORAL

Session for therapeutic education on household accidents

Control therapeutic education session

Eligibility Criteria

• Age: 3 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Presence of chronic pathology Family already included in the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Necker Hospital

Paris, 75015, France

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• François Angoulvant, MD, PhD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 16, 2018
• Study Start: September 26, 2018
• Primary Completion: September 24, 2021
• Study Completion: September 24, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)