CTRI/2017/10/010012CompletedPhase 3
Randomized controlled trial of two different doses of intravenous paracetamol for PDA closure in preterm infants less than 30 weeks
Surya Childrens Medicare Private limited0 sites102 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 102
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Preterm infants with a) gestation age less than 28weeks or b) between 28-30 weeks on invasive mechanical ventilation or on CPAP with FiO2 requirements more than 35%
- •having 2D echocardiographic evidence of hemodynamically significant PDA (duct size more than 1.5mm narrowest internal diameter, Left Atrium/Aorta more than 1.5, left to right flow across shunt, reversal of flow in distal aorta) diagnosed at 18-24 hours of life.
Exclusion Criteria
- •1.Infants having complex cyanotic heart disease or duct dependent cardiac lesion.
- •2.Infants who were admitted to hospital after 72 hours of life.
- •3.Infants perceived unlikely to survive the first week of life.
- •4.Antenatal diagnosed serious congenital anomaly such as multicystic dysplastic kidney and polycystic disease of kidney)
- •5.maternal tocolytic therapy with indomethacin or another prostaglandin inhibitor within 72 hrs prior to delivery
Investigators
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