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

Category Primary study
Registry of TrialsANZCTR
Year 2024
INTERVENTION: interventional drug dexamethasone, 0.25mg/kg , Intravenous infusion , 6 hourly , for 2 days will be given along with standard treatment(antibiotic therapy) .it will be prescribed by pediatrician, delivered and monitored by ward nurses. participants will be allowed to take other drugs/treatments related to the care of their parapneumonic effusion/pneumonia or other comorbidities and it will be recorded. CONDITION: Infection ‐ Other infectious diseases parapneumonic effusion; ; parapneumonic effusion Respiratory ‐ Other respiratory disorders / diseases PRIMARY OUTCOME: time to recovery of parapneumonic pleural effusion[recovery criteria includes clinical and radiological characteristics.; 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: 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.] 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.
Epistemonikos ID: 3de5149c9ec87153d17e69d4f064dd951aeebebc
First added on: Aug 28, 2024