Patent ductus arteriosus in the very low birth weight premature newborn Neonatal Diseases
Conditions
Interventions
This was a randomized prospective study in very low birth weight preterm newborns 1.4, measured in the left parasternal long axis
retrograde flow measured in the descending aorta, celiac or mesenteric artery.
Patients who met the inclusion criteria were randomized to acetaminophen or ibuprofen group, using an op
echocardiographic diagnosis of hs-PDA within the first 2 weeks after birth
admitted to the neonatal intensive care unit
Sponsors
University of Concepción
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Preterm newborns between 25+0 – 31+6 weeks of gestational age and/or =1500 g of birth weight 2. Echocardiographic diagnosis of hemodynamically significant PDA within the first 2 weeks after birth 3. Admitted to the neonatal intensive care unit of Guillermo Grant Benavente Hospital
Exclusion criteria
Exclusion criteria: 1. Major congenital malformations, fetal hydrops, complex or ductus-dependent congenital heart disease; septic shock grade III and IV intracranial hemorrhage 2. Renal failure with urine output 1.5 mg/dl; platelet count II) 6. Liver dysfunction defined as elevation of liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) over two times the upper limit of normal range (ALT 6-50 U/L and AST 35-140 U/L)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary closure of patent ductus arteriosus measured using the percentage of ductal closure after the first course of treatment with acetaminophen or ibuprofen at 72 h after the start of the first course of treatment 2. Secondary closure of patent ductus arteriosus measured using the percentage of ductal closure after the second course of treatment with acetaminophen or ibuprofen at 72 h after the start of the second course of treatment 3. Surgical closure of patent ductus arteriosus measured using the percentage of surgical ligation performed after the second course of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intraventricular hemorrhage measured using the percentage of intraventricular hemorrhage at the end of treatment with acetaminophen or ibuprofen 2. Pulmonary hemorrhage measured using the percentage of pulmonary hemorrhage at any time during the treatment with acetaminophen or ibuprofen 3. Early onset sepsis measured using the percentage of early-onset sepsis at any time during the treatment with acetaminophen or ibuprofen 4. Acute kidney injury measured using the percentage of acute kidney injury at any time during the treatment with acetaminophen or ibuprofen 5. Necrotizing enterocolitis measured using the percentage of necrotizing enterocolitis at any time during and after the treatment with acetaminophen or ibuprofen 6. Gastrointestinal bleeding measured using the percentage of gastrointestinal bleeding at any time during the treatment with acetaminophen or ibuprofen 7. Pneumonia measured using the percentage of pneumonia at any time during and after the treatment with acetaminophen or ibuprofen. 8. Late-onset sepsis measured using the percentage of late-onset sepsis at any time during and after the treatment with acetaminophen or ibuprofen 9. Retinopathy of prematurity measured using the percentage of retinopathy of prematurity at any time during and after the treatment with acetaminophen or ibuprofen 10. Broncopulmonary dysplasia measured using the percentage of broncopulmonary dysplasia at any time after the treatment with acetaminophen or ibuprofen 11. Primary closure of patent ductus arteriosus in patients weighing less than 1000 g measured using the percentage of ductal closure in patients weighing less than 1000 grams after the first course of treatment with acetaminophen or ibuprofen at 72 h after the start of the first course of treatment 12. Secondary closure of patent ductus | — |
Countries
Chile
Contacts
Public ContactAndres Marinovic
Outcome results
None listed