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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01443611
First received: September 27, 2011
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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.


Condition
Febrile Convulsions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Number of patients with abnormal lumbar puncture [ Time Frame: One year ] [ Designated as safety issue: No ]
    The number of patients aged six months to one year that underwent lumbar puncture when they were admitted with simple febrile convulsions


Estimated Enrollment: 300
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants with first episode of Febrile Convlusions

Detailed 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.

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443611

Locations
Israel
Pediatric Dpt B - Ha'Emek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01443611     History of Changes
Other Study ID Numbers: 0138-10-EMC
Study First Received: September 27, 2011
Last Updated: July 16, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Infants

Additional relevant MeSH terms:
Seizures, Febrile
Fever
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms
Neurologic Manifestations

ClinicalTrials.gov processed this record on August 21, 2014