Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates
Patent Ductus Arteriosus
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring PDA, Platelets
Eligibility Criteria
Inclusion Criteria:
- Gestational age up to 34 6/7 weeks
- PDA detected for the first time at less than 14 days of postnatal age
- Clinically and/or echocardiographically hemodynamically significant PDA Note: ELBW neonates will be screened in first 48 hours as per unit policy; the rest will undergo echocardiography only when there are clinical signs of PDA.
- Platelet count within 24 hours prior to inclusion is less than 100,000 per microliter.
Note: If a platelet count is already available within 24 hours prior to inclusion it will be accepted as a valid platelet count. If not, an urgent absolute platelet count will be performed.
Exclusion Criteria:
- Echocardiographically proven structural congenital heart disease.
- Major life-threatening malformation
- Received platelet concentrate between the last available platelet count and the point of randomisation
Sites / Locations
- Post Graduate Institute of Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Liberal Platelet transfusion group
Restrictive platelet transfusion group
Platelet transfusion to maintain a platelet count above 1,00,000 per microliter until one of the endpoints is met. As all subjects recruited in the trial will have hemodynamically significant (hs) PDA, they will all be medically treated as per standard of care. Treatment regimens will be as follows, depending on the discretion of the treating physician: Ibuprofen: Dosage-10 mg/kg stat followed by 5 mg/kg/dose x 2 doses at 24 hours intervals Route- oral Paracetamol: Dosage-15 mg/kg/dose every 6 hourly x 12 doses Route - IV
Platelet transfusion for standard criteria. As all subjects recruited in the trial will have hemodynamically significant (hs) PDA, they will all be medically treated as per standard of care. Treatment regimens will be as follows, depending on the discretion of the treating physician: Ibuprofen: Dosage-10 mg/kg stat followed by 5 mg/kg/dose x 2 doses at 24 hours intervals Route- oral Paracetamol: Dosage-15 mg/kg/dose every 6 hourly x 12 doses Route - IV