patent ductus arteriosus
Conditions
Interventions
Expectation management Group:No cyclooxygenase inhibitor intervention was given
The acetaminophen group:Oral (nasal feeding) acetaminophen (Tylenol suspension, Shanghai Johnson & Johnson Pharmaceutical Co., LTD., National drug approval number H19990006, 32 mg/ml, diluted to 15 mg
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 0.1 Years
Inclusion criteria
Inclusion criteria: (1) gestational age <32 weeks, 4~7 days. (2) haemodynamically significant patent ductus arteriosus (hsPDA) met the diagnostic criteria: Continuous left-to-right blood flow is present in the ductus arteriosus, the diameter of the ductus is =1.5 mm or the ratio of the diameter of the ductus to the diameter of the left pulmonary artery is =0.5, and at least one of the following criteria is met: 1) the ratio of the left atrial diameter to the diameter of the aortic root is =1.5; 2) Blood flow rate in catheter = 2.5m /s or mean pressure difference at both ends of catheter =8 mmHg; 3) diastolic blood regurgitation in descending aorta
Exclusion criteria
Exclusion criteria: (1) There were contraindications for the use of cyclooxygenase inhibitors (urine volume 141.5 µmol/L, glutamic-pyrugal transaminase >40) U/L, percutaneous oxygen saturation <90%, shock, diffuse intravascular coagulation, stage ? to III necrotizing enterocolitis, grade ? to ? intraventricular hemorrhage, hyperbilirubinemia requiring blood exchange, intestinal perforation, etc.) or use of cyclooxygenase inhibitors before randomization. (2) Persistent pulmonary hypertension (right-to-left shunt in =33% of cardiac cycles). (3) Severe cyanotic congenital heart disease (transposition of great arteries, tetralogy of Fallot, etc.). (4) Congenital malformations of respiratory system (atresia of posterior nostril, cleft palate, tracheoesophageal fistula, etc.). (5) Severe congenital malformations (trisomy 21 syndrome, congenital diaphragmatic hernia, omphalocele, etc.). (6) Congenital abnormalities associated with abnormal neurodevelopmental outcomes. (7) Vital signs are extremely unstable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of hsPDA at 14 to 17 days of age (management/treatment failure rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of hsPDA after 3-4 days of treatment (7-11 days of age);Rate of hsPDA at 36 weeks of discharge/corrected gestational age;BNP after 3 to 4 days of treatment;Rate of need for rescue treatment;Total number of days of respiratory support;Incidence of pulmonary hemorrhage and mortality;The incidence and mortality of moderate and severe BPD;Incidence and case fatality rate of ROP need treatment; | — |
Countries
China
Contacts
Public ContactGao Xiangyu
Xuzhou Central Hospital
Outcome results
None listed