Patent ductus arteriosus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Preterm neonates <= 35 completed weeks of gestation at birth with echocardiographic confirmation of a hemodynamically significant PDA (hsPDA) after 2 days of life; 2. Obtained the informed consent of parents; 3. All infants has an indwelling vascular catheter; 4. All infants has an stomach tube.
Exclusion criteria
Exclusion criteria: 1. Neonates with being allergic to COX inhibitor; 2. Hyperbilirubinemia; 3. Infection or suspected infection; 4. Intraventricular haemorrhage or gastrointestinal bleeding; 5. Coagulation or thrombocytopenia; 6. Necrotizing enterocolitis; 7. Renal dysfunction (serum creatinine > 1 mg/dL), oliguria (< 1 mL/kg/h); 8. Ductus arteriosus dependent congenital heart disease (pulmonary atresia, tetralogy of Fallot or coarctation aorta).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of ibuprofen;Area under the curve (AUC) from zero to infinity;Area under the curve (AUC) 0-t;Gestational age, Gender, Birth weight;Indexes such as urine volume, liver and kidney function before and after administration;Diameter of arterial duct, LA/AO, LVEF, Pulmonary artery flow rate and other indicators before and after administration;Maximum peak concentration of ibupeofen; | — |
Countries
China
Contacts
the Affiliated Yongchuan Hospital of Chongqing Medical University