NSAIDs Treatment in Children With Pleuropneumonia

November 13, 2014 updated by: Rabin Medical Center

The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial

The purpose of this study is to evaluate the influence of routine NSAIDs treatment for hospitalized children with pleuropneumonia in comparison with acetominophen treatment (all in conjunction with adequate antibiotic therapy).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: havatzelet yarden-bilavsky, Dr
  • Phone Number: 972-54-6777054
  • Email: yojiby@gmail.com

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Recruiting
        • Schneider's medical center of Israel
        • Contact:
        • Principal Investigator:
          • Havatzelet -- Yarden-Bilavski, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age less than 18 years
  • admission in Schneider childrenMC of Israel, wards a/c
  • clinical diagnosis of pneumonia with evidence of pleural effusion on chest X-ray
  • parental informed consent
  • follow-up ability after discharge

Exclusion Criteria:

  • pneumonia secondary to foreign body aspiration
  • immune deficiency
  • chronic lung disease other than asthma (CF, CLD of prematurity, Familial Dysautonomia, etc)
  • significant premorbidity (organ failure, rheumatic disease, etc)
  • endotracheal/endobronchial devices including tracheostomy.
  • parental refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ibuprofen
Drug: Ibuprofen
10 mg/kg every 8 hours until 24 hours after resolution of fever
Other Names:
  • advil
  • nurofen
Active Comparator: acetaminophen
Drug: Acetaminophen
15 mg/kg every 6 hours until 24 hours after resolution of fever
Other Names:
  • paracetamol
  • acamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical improvement as manifested by resolution of fever and length of hospital admission.
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
participants will be followed for the duration of hospital stay, an expected average of 10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical improvement as manifested by respiratory parameters (tachypnea, dyspnea, Fio2),and inflammatory markers.
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 10 days
participants will be followed for the duration of hospital stay, an expected average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: havatzelet yarden-bilavsky, MD, schneider children MC of Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Estimate)

November 14, 2014

Last Update Submitted That Met QC Criteria

November 13, 2014

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262-11-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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