Paracetamol versus Ibuprofen For Closure of Patent Ductus Arteriosus
- Conditions
- Health Condition 1: null- Preterm Neonates less than or equal to 34weeks or less than or equal to 1800gms
- Registration Number
- CTRI/2017/10/009989
- Lead Sponsor
- Vivek Kumar Athwani
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Preterm neonates born at less than or equal to 34 weeks or birth weight less than or equal to 1800gms with hemodynemically significant Patent Ductus Arteriosus
If any one of the following present
(1)Congenital heart disease which required PDA to maintain blood flow;
(2)Septic shock;
(3) Recent (within the previous 24 h) IVH,grade 3â??4;
(4) Urine output less than 1 ml/kg/h in preceding 8h;
(5) Serum creatinine more than 1.0mg/dl;
(6) Platelet count less than 50000/mm3;
(7) Hyper-bilirubinemia requiring exchange transfusion;
(8) necrotizing enterocolitis;
(9)Severe liver failure, defined as elevated liver enzymes SGOT/SGPT more than 2times, the upper limit of normal range;
(10)Previous treatment with paracetamol, ibuprofen or any COX inhibitor, for any purpose;
(11)Refusal of consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary closure rate of PDA after the first course of the drugTimepoint: Till recruitment of last patient as calculated in sample size.
- Secondary Outcome Measures
Name Time Method