CTRI/2016/09/007261
Completed
Phase 3
Comparison of oral paracetamol versus ibuprofen for PDA closure in preterms â?? a randomized controlled single blinded study - IPOD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- JIPMER
- Enrollment
- 150
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preterm neonates \< 37 completed weeks , \< 2500 g with features of PDA with any one of the following
- •1\. Congestive cardiac failure
- •2\. Mechanical ventilation
- •3\. LA / Aortic root ratio \> 1\.5
Exclusion Criteria
- •Presence of other cardiac anomalies or duct dependant lesions.
- •2\.Major congenital malformations.
- •3\.Oliguria ( urine output \< 1ml/Kg/hour during the preceding 24 hours)
- •4\.S. creatinine \>1\.6mg/dl
- •5\.Intra ventricular hemorrhage within the last 24 hours
- •6\.Necrotizing enterocolitis
- •7\.Abnormal liver function test.
- •8\.Platelet count \< 50,000 or overt bleeding
Outcomes
Primary Outcomes
Not specified
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