The Relevance of Performing Lumbar Puncture in Infants Aged 3 to 12 Months With First Episode of Febrile Convulsion

Febrile Convulsions Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01443611
• Other study ID #: 0138-10-EMC
• Status: Completed
• Phase: N/A
• First received: September 27, 2011
• Last updated: August 30, 2015
• Start date: June 2011
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The actual recommendations for infants aged 3 to 12 months presented with first episode of Febrile Convulsions highly recommend performing lumbar puncture in order to rule out Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal vaccination arise the question if in the presence of a normal physical examination those recommendations are still relevant. The purpose of this study is to summarized retrospectively the clinical records of all the infants admitted to the pediatric wards in the ten years period since 2000 to 2010 in order to record the incidence of Bacterial Meningitis among infants admitted with the First episode of Febrile Convulsions.

Description:

Demographic data, including ethnic origin, age an gender will be recorded. The type of Convulsions (Simple or Complex), duration, and time since the fever was noticed will be also recorded. Another data that will be summarized included: previous antibiotic treatment, physical examination with special emphasis on neurological examination and meningeal signs, routine laboratory analysis including blood count and cerebrospinal fluid (CSF) results and the final diagnosis including the cause of fever.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 12 Months

Eligibility

Inclusion Criteria:

• Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions during the period 1/1/2000 until 31/12/2010

Exclusion Criteria:

• infants with previous neurological diseases, or

• recent neurological disease that are not included in the characteristics of Febrile Convulsion

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Febrile Convulsions
• Seizures
• Seizures, Febrile

Locations

Country	Name	City	State
Israel	Pediatric Dpt B - Ha'Emek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with abnormal lumbar puncture	The number of patients aged six months to one year that underwent lumbar puncture when they were admitted with simple febrile convulsions	One year	No