Patent Ductus Arteriosus in Preterm Infants patent ductus arteriosus, preterm infants, drug therapy, renal dysfunction, safety, efficacy
Conditions
Interventions
Intravenous Paracetamol Therapy
Paracetamol is administered at a dose of 15 mg/kg every 6 hours over 15 minutes, 4 times a day. Dosing should be continued for 3 consecutive days. If closure of the duc
D000082
drug therapy, acetaminophen, paracetamol
Sponsors
Namba Fumihiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newborn infants with a gestational age of at least 22 weeks but less than 35 weeks and birth weight of at least 400 g but less than 2,000 g 2. Newborn infants who can receive the study drug immediately up to 14 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
Exclusion criteria
Exclusion criteria: 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 (However, small doses of hydrocortisone (less than or equal to 2 mg/kg/dose) are acceptable.) 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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of renal dysfunction from the start of treatment to 48 hours after the end of treatment Renal dysfunction: One of the following is met 1. Serum creatinine level: 0.3 mg/dL or 1.5-fold increase from baseline (screening period) 2. Urine output <1 mL/kg/H (24 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of ductus arteriosus closure at 24 hours after completion of study drug administration 2. Percentage of successful treatment (percentage of patients free from hemodynamically significant patent ductus arteriosus) at 24 hours after completion of study drug administration 3. Percentage of reopening of the ductus arteriosus between 24 and 48 hours after completion of study drug administration 4. Gastric and gastrointestinal bleeding from the start of the study drug administration to 48 hours after the end of the study drug administration 5. Perforation of stomach or gastrointestinal tract from the start of the study drug administration to 48 hours after the end of the study drug administration 6. Incidence of adverse drug reactions from the start of the study drug administration to 48 hours after the end of the study drug administration 7. Changes in the following laboratory values on the day of study drug administration start and 24 and 48 hours after the end of study drug administration (1) Platelet count (2) Serum urea nitrogen (BUN) level (3) Serum creatinine (Cr) level (4) Serum bilirubin (Bil) level (5) Serum aspartate aminotransferase (AST) level (6) Serum alanine aminotransferase (ALT) level (7) Serum glucose level (8) 24-hour urine output (mL/kg/H) (9) Blood NTproBNP | — |
Contacts
Public ContactFumihiko Namba
Saitama Medical Center, Saitama Medical University
Outcome results
None listed