JPRN-jRCTs031220386招募中3 期
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Intravenous Paracetamol for Treatment of Patent Ductus Arteriosus in Preterm Infants - iPAPP trial
amba Fumihiko0 个研究点目标入组 110 人开始时间: 2022年10月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
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
- 年龄范围
- >= 至 <= 1weeks old（—）
- 性别
- All
入选标准
- •1. Newborn infants with a gestational age of at least 24 weeks but less than 35 weeks and birth weight of at least 500 g but less than 2,000 g
- •2. Newborn infants who can start receiving the study drug 24 hours to 7 days after birth
- •3. Newborn infants diagnosed with hemodynamically significant patent ductus arteriosus who meet both (1) and (2) below
- •(1) Left and right shunts
- •(2) One of the following
- •1) Arterial duct inner diameter > 1.5 mm
- •2) Left atrium to aorta ratio (LA/Ao) > 1.5
- •3) End-diastolic retrograde blood flow in the superior mesenteric artery or anterior cerebral artery
- •4. Newborn infants for whom written consent has been obtained from a surrogate
排除标准
- •1. Newborn infants with a history of drug therapy for patent ductus arteriosus
- •(However, a small prophylactic dose of indomethacin for prevention of intraventricular hemorrhage is permitted.)
- •2. Newborn infants with a history of systemic administration of steroids within 24 hours of enrollment
- •3. Newborn infants with congenital heart disease (not including patent foramen ovale or left superior vena cava remnant)
- •4. Newborn infants with congenital malformation
- •5. Newborn infants with fetal hydrops
- •6. Newborn infants with a severe infection (positive blood culture at birth)
- •7. Newborn infants with pulmonary hypertension diagnosed by echocardiography (presence of foramen ovale or right-left shunt of ductus arteriosus)
- •8. Newborn infants with intraventricular hemorrhage (grade 3 or 4)
- •9. Newborn infants with hyperbilirubinemia requiring exchange transfusion
- •10. Newborn infants with necrotizing enterocolitis (Bell Classification 2 or 3)
- •11. Newborn infants with perforation of the stomach or gastrointestinal tract
- •12. Newborn infants with a bleeding tendency (hematuria, blood in tracheal aspirate, gastric aspirate, or stool, or persistent bleeding from the puncture site)
- •13. Newborn infants with a serum creatinine (Cr) level > 1.5 mg/dL during the screening period
- •14. Newborn infants with a urine output <1 mL/kg/H for 24 hours immediately before enrollment or <0.5 mL/kg/H for 24 hours after birth
- •15. Newborn infants with a platelet count <50,000/ul during the screening period
- •16. Newborn infants with an increase in ALT or AST of more than twice the normal value during the screening period.
- •(Normal values: ALT 6-50 U/L; AST 35-140 U/L)
- •17. Newborn infants who are judged to be ineligible for participation in this study by the principal investigator or a research associate.
- •(The laboratory values used to determine the exclusion criteria may be based on the results of tests performed prior to consent.)
研究者
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