NSAIDs Treatment in Children With Pleuropneumonia
The Role of Non Steroidal Anti Inflammatory Drugs in the Treatment of Pleuropneumonia in Children. a Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 14, 2014
January 1, 2012
3.3 years
March 19, 2012
November 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical improvement as manifested by resolution of fever and length of hospital admission.
participants will be followed for the duration of hospital stay, an expected average of 10 days
Secondary Outcomes (1)
clinical improvement as manifested by respiratory parameters (tachypnea, dyspnea, Fio2),and inflammatory markers.
participants will be followed for the duration of hospital stay, an expected average of 10 days
Study Arms (2)
ibuprofen
EXPERIMENTALacetaminophen
ACTIVE COMPARATORInterventions
10 mg/kg every 8 hours until 24 hours after resolution of fever
15 mg/kg every 6 hours until 24 hours after resolution of fever
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider's medical center of Israel
Petah Tikva, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
havatzelet yarden-bilavsky, MD
schneider children MC of Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2012
First Posted
April 26, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 14, 2014
Record last verified: 2012-01