Back to resultsNSAIDs Treatment in Children With Pleuropneumonia
Primary Purpose
Pleuro-pneumonia
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Pleuro-pneumonia focused on measuring pleuropneumonia children, non steroidal anti inflammatory drugs, pleural effusion, severe pneumonia
Eligibility Criteria
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.
Sites / Locations
- Schneider's medical center of IsraelRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ibuprofen
acetaminophen
Arm Description
Outcomes
Primary Outcome Measures
clinical improvement as manifested by resolution of fever and length of hospital admission.
Secondary Outcome Measures
clinical improvement as manifested by respiratory parameters (tachypnea, dyspnea, Fio2),and inflammatory markers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01586299
Brief Title
NSAIDs Treatment in Children With Pleuropneumonia
Official Title
The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleuro-pneumonia
Keywords
pleuropneumonia children, non steroidal anti inflammatory drugs, pleural effusion, severe pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ibuprofen
Arm Type
Experimental
Arm Title
acetaminophen
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
nurofen, advil
Intervention Description
10 mg/kg every 8 hours until 24 hours after resolution of fever
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
paracetamol, acamol
Intervention Description
15 mg/kg every 6 hours until 24 hours after resolution of fever
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shai ashkenazi, Prof
Phone
972-3-9253680
Email
sashkenazi@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
havatzelet yarden-bilavsky, Dr
Phone
972-54-6777054
Email
yojiby@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
havatzelet yarden-bilavsky, MD
Organizational Affiliation
schneider children MC of Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider's medical center of Israel
City
Petah Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Havatzelet -- Yarden-Bilavski, MD
Phone
+972-3-9253680
Email
yoji@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Havatzelet -- Yarden-Bilavski, MD
12. IPD Sharing Statement
Learn more about this trial
NSAIDs Treatment in Children With Pleuropneumonia
We'll reach out to this number within 24 hrs