Health Condition 1: null- Neonates with gestational age less than 35 weeks with hemodynamically significant PDA
Conditions
Interventions
Intervention1: Platelet transfusion: We will transfuse platelet concentrates to maintain platelet count above 1, 00,000 per micro liter until one of the following endpoints is met, whichever is applic
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: 1) Gestational age less than 35 weeks 2) PDA detected for the first time at less than 14 days of postnatal age 3) 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. 4) 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
Exclusion criteria: Echocardiographically proven structural congenital heart disease. 2) Major life-threatening malformation 3) Received platelet concentrate between the last available platelet count and the point of randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable will be time to closure of PDA post randomizationTimepoint: The primary outcome variable will be time to closure of PDA post randomization within a 5 day period | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical bleed of any kind within 120 hours after randomizationTimepoint: 120 hours after randomization;Cumulative volume of platelet concentrate received within 120 hours after randomizationTimepoint: 120 hours after randomization;Duration of hospital stayTimepoint: Duration of hospital stay;Mortality anytime during hospital stayTimepoint: anytime during hospital stay;Mortality within 120 hours after randomizationTimepoint: 120 hours after randomization;New onset IVH of any grade within 120 hours after randomizationTimepoint: 120 hours after randomization;New onset IVH of grade 3,4 within 120 hours after randomizationTimepoint: 120 hours after randomization;Proportion in whom PDA is echocardiographically hemodynamically significant at 120 hours after randomizationTimepoint: 120 hours after randomization;Proportion in whom PDA is open at 120 hours after randomizationTimepoint: 120 hours after randomization;Reopening rate of PDA that had initially closed within 120 hours of randomizationTimepoint: within 120 hours of randomization | — |
Countries
India
Contacts
Public ContactSOURABH DUTTA
Post Graduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed