To determine the effectiveness and safety of high dose ibuprofen compared with standard dose ibuprofen for closing a patent ductus arteriosus (an open vascular channel between the lungs and the heart) in preterm, lowâ??birthâ??weight, or preterm and lowâ??birthâ??weight infants.
Not Applicable
- Conditions
- Health Condition 1: Q250- Patent ductus arteriosus
- Registration Number
- CTRI/2020/06/026183
- Lead Sponsor
- Dr Kishor Gandhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All preterm babies < 36 weeks admitted to NICU with hemodynamically significant PDA
Exclusion Criteria
A.Neonates with critical congenital cardiac disease
B.Neonates with contraindication for the Ibuprofen
1.Thrombocytopenia â?? PLT <60,000 per microliter of blood.
2.IVH grade 2 or more
3.NNEC grade 2 or more
4.Serum creatinine >1.6 MG/DL
5.Serum Urea >60 MG/DL
6.Serum bilirubin level within 2mg/dl of the exchange range as per NICE guidelines.
7.Coagulopathy â?? deranged PT or aPTT value (adjusted for gestational age and post natal age).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method