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OpenTrials
Completed

NCT Number: NCT01443611

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

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.

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Key information

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Dpt B - Ha'Emek Medical Center

Afula, 18101, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with abnormal lumbar puncture

    Time frame: One year

    The number of patients aged six months to one year that underwent lumbar puncture when they were admitted with simple febrile convulsions

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 30, 2011
Registry last updated
Sep 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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