Health Condition 1: null- Patent Ductus Areteiosus(PDA)
Conditions
Interventions
Intervention1: Paracetamol: For PDA closure in preterm neonates(32 weeks).15 mg per kg q 6 hrly for 3 days in first course and same dose in second course till the time PDA is patent.
Control Intervent
Sponsors
PGIMER
Eligibility
Inclusion criteria
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 • Antegrade main pulmonary artery diastolic flow >20 cm/sec • E wave to A wave ratio >1 • Isovolemic relaxation time (IVRT) • Absent or reversed diastolic blood flow pattern in descending thoracic aorta
Exclusion criteria
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 5.Refusal of consent by parents
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Azotemia, oliguria, hepatitis with deranged liver transaminases, deranged coagulogram, intraventricular hemorrhage (any grade of severity), severe intraventricular hemorrhage (grade 3 and intra-parenchymal extension), periventricular leukomalacia, necrotizing enterocolitis (all stage), necrotizing enterocolitis (definite and advanced stage as per modified Bellâ??s staging), feed intolerance, broncho-pulmonary dysplasia, and retinopathy of prematurityTimepoint: Any time;â?¢ Reopening of PDA following initial closure â?¢ Plasma Paracetamol and Ibuprofen levels 30 minutes after the administration of the first dose on second day of the study drug â?¢ Echo proven pulmonary artery hypertension Timepoint: Any time;â?¢Closure of PDA following a single course of study drug â?¢Closure of PDA following surgical ligation â?¢Death (due to any cause) before discharge from the hospital â?¢Reopening of PDA following initial closure Timepoint: Any time | — |
Primary
| Measure | Time frame |
|---|---|
| Closure of PDATimepoint: 96 hours | — |
Countries
India
Contacts
Public ContactDr Sourabh Dutta
PGIMER
Outcome results
None listed