Steroid therapy and outcome of parapneumonic effusion in children :a randomized controlled trial

Phase 4

Recruiting

Conditions: parapneumonic effusion
Infection - Other infectious diseases
Respiratory - Other respiratory disorders / diseases

Registration Number: ACTRN12624000325505

Lead Sponsor: niversity of child health sciences,Children hospital Lahore

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 38

Inclusion Criteria

Children (2 mo-14 y) admitted for pneumonia (defined as fever >1oo.4 F with cough and chest
radiography showing parenchymal lesion) with pleural effusion.

Exclusion Criteria

Immunodeficiency/chronic lung conditions, Hemodynamic instability requiring cardiac / ventilator support ,Allergy to any of the drugs included in study, Contraindications to steroids, children already taking steroid therapy, Known diabetics, Children with comorbid conditions, ,Active tuberculosis, Blood glucose level above 200 mg/dl at time of enrolment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
time to recovery of parapneumonic pleural effusion[recovery criteria includes clinical and radiological characteristics.<br> Clinical criteria include axillary temperature taken by digital thermometer should be < 99.5 F for 12 hours and absence of respiratory distress defined by age related normal range respiratory rate, Ward nurse will monitor for temperature and respiratory rate 6 hourly and document on vital monitoring chart. Radiological criteria will be amount of effusion on ultrasound measured in ml by radiologist.. baseline and 72 hours post intervention(dexamethasone) temperature, respiratory rate and amount of effusion on ultrasonography. Temperature and respiratory rate will be monitored 6 hourly for 72 hours after inclusion in the trial while ultrasound assessment will be done twice, initially at time of participation in trial (baseline) and later on 4th day i.e. 72 hours after treatment. ]

Secondary Outcome Measures

Name	Time	Method
length of hospital stay[assessed from medical records from date of recruitment in clinical trial and receiving intervention till discharge from hospital ];progression of simple parapneumonic effusion requiring drainage[ultrasonographic measurement of effusion in ml ultrasound will be done at time of participation in trial (baseline) and 72 hours post treatment/ intervention. However it can be done earlier if there is worsening of respiratory distress and clinical suspicion is of progression in size of effusion.]