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Platelet Transfusion for Treatment of Patent Ductus Arteriosus in ThrombocytopenicPreterm Neonates

Phase 3
Conditions
Health Condition 1: null- Neonates with gestational age less than 35 weeks with hemodynamically significant PDA
Registration Number
CTRI/2017/01/007660
Lead Sponsor
Postgraduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
44
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
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