CTRI/2014/08/004805已完成2 期
Oral Paracetamol versus Oral Ibuprofen for closure of Hemodynamically significant Patent Ductus Arteriosus in Preterm Neonates (32 weeks):A Blinded Randomized Controlled Non-Inferiority Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- PGIMER
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
研究者
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