A study of comparison of Paracetamol vs Ibuprofen in closing PDA(a connection between two main vessel during fetal life ) in babies born before their due date of delivery.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

a) Inborn preterm neonates born at less than 32 weeks of gestation

b) Presence of a hemodynamically significant PDA

A PDA would be defined as HS-PDA if any one of the below mentioned clinical/biochemical sign is present in the presence of a PDA with a trans ductal diameter of >= 1.6 mm (or) in the presence of any one of the below mentioned echocardiographic sign suggestive of hemodynamic significance even in the absence of any of the below mentioned clinical/biochemical sign. A screening Echo would be done in all asymptomatic neonates to detect HS-PDA and this would be timed in first 24 hours for less than 28 weeks gestation, in the first 48 hours for 28-29 weeks of gestation and between 48-72 hours of age in infants 30-31 weeks gestation.Following clinical features would be considered as suggestive of a HS-PDA (if not explained by an alternative reason):Hyperdynamic pulsatile precordium, bounding peripheral pulses, wide pulse pressure ( >25 mmHg),poor peripheral pulse volume, prolonged capillary refill time, decreased urine output, deranged renal function test, metabolic acidosis, and hypotension,abnormal weight gain, increase in liver size, new onset or increase in ventilatory requirements that primarily involves PEEP, PIP and FiO2, respiratory acidosis, pulmonary crepitations, hemorrhagic pulmonary edema

Following echocardiographic features would be indicative of a HS-PDA:

A trans-ductal diameter at the pulmonary end >= 1.5 mm along with any one of the following:

•Evidence of left atrial enlargement (LA: Ao root diameter ratio >=1.4)

•Ductal velocity < 2 meters/sec

•Antegrade main pulmonary artery diastolic flow >20 cm/sec

•E wave to A wave ratio >1

•Isovolemic relaxation time (IVRT) <=45 milliseconds

•Absent or reversed diastolic blood flow pattern in descending thoracic aorta

Exclusion Criteria

1.Antenatally or postnatally suspected or diagnosed structural heart disease

2.Presence of major congenital malformations

3.Contraindication for enteral feeding

4.Contraindication for administration of any one of the study drugs such as Blood Urea > 60mg/dL, serum creatinine level >1.6 mg/ dL, platelet count <60000/mm3, clinical bleeding from any site, deranged coagulogram, clinical or radiological evidence of necrotizing enterocolitis, intra-ventricular hemorrhage of moderate to severe grade severity (grade III with or without intra-parenchymal extension) or progression of intra-ventricular hemorrhage demonstrated in an earlier ultrasound, hyperbilirubinemia within 2 mg/dl from the exchange transfusion cut-off value

5.Refusal of consent by parents