Trial reportItalian journal of pediatrics2026
Comparison of two targeted rescue treatments after the first week of expectant managment for very preterm infants with hemodynamically significant patent ductus arteriosus: a prospective study.
Trial report in Italian journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundTo investigate the clinical value of early expectant management of very preterm infants with hemodynamically significant patent ductus arteriosus (hsPDA), and the efficacy and safety of rescue treatment with oral acetaminophen or high-dose ibuprofen.
methodsThe very preterm infants with hsPDA (gestational age ≤ 32 weeks and age 4-6 days) who were admitted to the neonatal intensive care unit of Xuzhou Central Hospital between February 2022 and December 2024 were enrolled in the study. If the patient still met the diagnostic criteria of hsPDA after 3-4 days of expectant management, the rescue treatment shall be given. They were randomly divided into the acetaminophen group (oral acetaminophen 15 mg/kg, once every 6 hours for 3 days) and the high-dose ibuprofen group (oral ibuprofen 20 mg/kg for the first time, 10 mg/kg for the 24 hours and the 48 hours respectively). Before and after treatment, routine blood tests, biochemical items (including serum Cystatin C, serum creatinine, alanine aminotransferase and total serum bilirubin), urinary Cystatin C, B-type natriuretic peptide, and fecal occult blood were measured; bedside echocardiography and brain standard ultrasound were performed; and urine output and complications were recorded. The data were analyzed by t-test, rank sum test and chi-square test with SPSS 20.0 statistical software.
results167 (54.4%) of 307 very preterm infants with hsPDA showed spontaneous closure in the first 7-10 days of life. There was no significant difference in the success rate of rescue treatment between the acetaminophen group and the high-dose ibuprofen group [82.0% (50/61) vs. 77.8% (49/63), P=0.561]. During rescue treatment, the upper gastrointestinal bleeding rate, positive fecal occult blood tests and oliguria rate of high-dose ibuprofen group were higher than those of the acetaminophen group, but the difference was not statistically significant (P>0.05). The incidence of stage Ⅱ-Ⅲ necrotizing enterocolitis and stage Ⅲ-Ⅳ intraventricular hemorrhage in the two groups were lower, and the difference was not statistically significant (P>0.05). After rescue treatment, the serum Cystatin C of high-dose ibuprofen group was higher than that of acetaminophen group [(1.66±0.30) mg/L vs. (1.55±0.24) mg/L], the urinary Cystatin C of high-dose ibuprofen group was higher than that of acetaminophen group [(80.00±32.96) ng/mL vs. (66.50±26.77) ng/mL], and the 24-hours urine output was lower than that of acetaminophen group [(2.66±1.32) ml/(kg•h) vs. (3.29±1.15) ml/(kg•h)], with statistical significance (P=0.018, 0.014, 0.290). After rescue treatment, there were no significant differences in serum creatinine, platelet count, B-type natriuretic peptide, alanine aminotransferase, and total serum bilirubin between the two groups (P>0.05).
conclusionIn the early stage (7-10 days after birth) of very preterm infants with hsPDA, the spontaneous closure rate of hsPDA during expectant management can reach more than 50%. After the failure of expectant management, rescue treatment with oral acetaminophen or high-dose ibuprofen can be started on the 7th to 10th day after birth, and the success rate is about 80%, and was relatively safe. The effect of oral high-dose ibuprofen on renal function may be greater than that of acetaminophen.
trial registrationChinese Clinical Trial Registry, ChiCRT2200056444. Registered 06 February 2022, https://www.chictr.org.cn/showproj.html?proj=151092.
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