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Late Acetaminophen Therapy for Patent Ductus Arteriosus in the Preterm Neonate.

ABSTRACT: OBJECTIVE:In preterm infants, the standard pharmacologic treatment for a hemodynamically significant patent ductus arteriosus (hsPDA) is either ibuprofen or indomethacin. However, these medications may be less effective after 2 weeks of age. We investigated the use of acetaminophen in hsPDA closure beyond 2 weeks of age. METHODS:An observational study of 11 infants, <30 weeks' gestation at birth and postnatal age > 2 weeks, who received acetaminophen treatment for their hsPDA. Echocardiograms (ECHOs), B-type natriuretic peptide (BNP) levels, and the fraction of inspired oxygen (FiO2) were obtained before and after treatment to analyze ductal characteristics. Renal and liver functions were monitored pretreatment and posttreatment to look for potential medication side effects. RESULTS:Of the 10 infants with ECHO data for before and after acetaminophen treatments, 4/10 (40%) had a decrease in PDA size, with no infants having complete closure immediately posttreatment. Eight of 11 (73%) infants had a decreased FiO2 requirement after treatment. Of the 5 infants with pretreatment and posttreatment BNP data, 2/5 (40%) infants had a decrease in BNP level. One infant received an additional course of acetaminophen. Four infants underwent a surgical ligation. Two infants died. No medication side effects occurred with regard to hepatic and renal function. CONCLUSION:Acetaminophen is a safe and effective pharmacologic treatment to reduce the significance of the hsPDA in some infants beyond 2 weeks of age, as shown by ECHO and BNP data.

SUBMITTER: King R

PROVIDER: S-EPMC7439953 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Late Acetaminophen Therapy for Patent Ductus Arteriosus in the Preterm Neonate.

King Ronnelle R Colon Michael M Stanfel Laura L Tauber Kate A KA

The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG 20200101 6

<h4>Objective</h4>In preterm infants, the standard pharmacologic treatment for a hemodynamically significant patent ductus arteriosus (hsPDA) is either ibuprofen or indomethacin. However, these medications may be less effective after 2 weeks of age. We investigated the use of acetaminophen in hsPDA closure beyond 2 weeks of age.<h4>Methods</h4>An observational study of 11 infants, <30 weeks' gestation at birth and postnatal age > 2 weeks, who received acetaminophen treatment for their hsPDA. Ech ...[more]

PMID: 32839654

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Project description:BackgroundSymptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a non-selective cyclooxygenase inhibitor, has demonstrated short-term clinical benefits. The effect of indomethacin in preterm infants with a symptomatic PDA remains unexplored.ObjectivesTo determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic PDA.Search methodsWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 31 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.Selection criteriaWe included RCTs and quasi-RCTs that compared indomethacin (any dose, any route) versus placebo or no treatment in preterm infants.Data collection and analysisWe used the standard methods of Cochrane Neonatal, with separate evaluation of trial quality and data extraction by at least two review authors. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of PDA closure within one week of administration of the first dose of indomethacin; bronchopulmonary dysplasia (BPD) at 28 days' postnatal age and at 36 weeks' postmenstrual age; proportion of infants requiring surgical ligation or transcatheter occlusion; all-cause neonatal mortality; necrotizing enterocolitis (NEC) (≥ Bell stage 2); and mucocutaneous or gastrointestinal bleeding.Main resultsWe included 14 RCTs (880 preterm infants). Four out of the 14 included studies were judged to have high risk of bias in one or more domains. Indomethacin administration was associated with a large reduction in failure of PDA closure within one week of administration of the first dose (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.23 to 0.38; risk difference (RD) -0.52, 95% CI -0.58 to -0.45; 10 studies, 654 infants; high-certainty evidence). There may be little to no difference in the incidence of BPD (BPD defined as supplemental oxygen need at 28 days' postnatal age: RR 1.45, 95% CI 0.60 to 3.51; 1 study, 55 infants; low-certainty evidence; BPD defined as supplemental oxygen need at 36 weeks' postmenstrual age: RR 0.80, 95% CI 0.41 to 1.55; 1 study, 92 infants; low-certainty evidence) and probably little to no difference in mortality (RR 0.78, 95% CI 0.46 to 1.33; 8 studies, 314 infants; moderate-certainty evidence) with use of indomethacin for symptomatic PDA. No differences were demonstrated in the need for surgical PDA ligation (RR 0.66, 95% CI 0.33 to 1.29; 7 studies, 275 infants; moderate-certainty evidence), in NEC (RR 1.27, 95% CI 0.36 to 4.55; 2 studies, 147 infants; low-certainty evidence), or in mucocutaneous or gastrointestinal bleeding (RR 0.33, 95% CI 0.01 to 7.58; 2 studies, 119 infants; low-certainty evidence) with use of indomethacin compared to placebo or no treatment. Certainty of evidence for BPD, surgical PDA ligation, NEC, and mucocutaneous or gastrointestinal bleeding was downgraded for very serious or serious imprecision.Authors' conclusionsHigh-certainty evidence shows that indomethacin is effective in closing a symptomatic PDA compared to placebo or no treatment in preterm infants. Evidence is insufficient regarding effects of indomethacin on other clinically relevant outcomes and medication-related adverse effects.

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Late Acetaminophen Therapy for Patent Ductus Arteriosus in the Preterm Neonate.

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Late Acetaminophen Therapy for Patent Ductus Arteriosus in the Preterm Neonate.

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