Platelet Transfusion for Treatment of Patent Ductus Arteriosus in Thrombocytopenic Preterm Neonates
Status:
Completed
Trial end date:
2017-03-20
Target enrollment:
Participant gender:
Summary
Patent ductus arteriosus (PDA) is a common problem in preterm babies. Recently there have
been various studies for and against an association between thrombocytopenia and PDA. A
meta-analysis published in 2015 showed a marginally significant positive association between
PDA and thrombocytopenia but these were all observational studies and there are no randomized
controlled trials (RCT) on it. The investigators decided to conduct an RCT to determine
whether liberal platelet transfusion criteria achieve earlier PDA closure rates than standard
restrictive platelet transfusion criteria among thrombocytopenic preterm neonates (<35 weeks'
gestation) with hemodynamically significant PDA presenting within the first 14 days of life.
The investigators primary objective is to determine whether liberal platelet transfusion
criteria achieve earlier PDA closure rates within 120 hours compared to standard restrictive
platelet transfusion criteria among thrombocytopenic preterm neonates (<35 weeks' gestation)
with hemodynamically significant PDA presenting within the first 14 days of life.
The investigators will stratify the study population based on platelet count, i.e < 50000 and
50000-100000 per microlitre, and will randomly allocate participants to control and
intervention group. Babies in the intervention group will receive platelet transfusion to
maintain the platelet count above 100,000 per microlitre. Babies in control group will
receive platelets only when clinically indicated and as per current standard indications. The
investigators will perform an echocardiogram at baseline to document a hemodynamically
significant PDA (hsPDA) and then serially to look for the closure of PDA. Medical management
of PDA will be as per unit policy. The investigators will follow the baby till PDA closes or
120 hours post randomization.
Phase:
Phase 3
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research