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high doses ibuprofen ductus arteriosus

Souvik Mitra, Ivan D Florez, Maria E Tamayo, Lawrence Mbuagbaw, Thuva Vanniyasingam, Areti Angeliki Veroniki, Adriana M Zea, Yuan Zhang, Behnam Sadeghirad, Lehana Thabane
Importance: Despite increasing emphasis on conservative management of patent ductus arteriosus (PDA) in preterm infants, different pharmacotherapeutic interventions are used to treat those developing a hemodynamically significant PDA. Objectives: To estimate the relative likelihood of hemodynamically significant PDA closure with common pharmacotherapeutic interventions and to compare adverse event rates. Data Sources and Study Selection: The databases of MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched from inception until August 15, 2015, and updated on December 31, 2017, along with conference proceedings up to December 2017...
March 27, 2018: JAMA: the Journal of the American Medical Association
Nihat Demir, Erdal Peker, İbrahim Ece, Ragıp Balahoroğlu, Oğuz Tuncer
BACKGROUND: To compare rectal ibuprofen with oral ibuprofen for the closure of hemodynamically significant patent ductus arteriosus (hsPDA) in very low birth weight (VLBW) preterm infants. STUDY DESIGN AND SUBJECTS: In a prospective, randomized study, 72 VLBW infants who had hsPDA received either rectal or oral ibuprofen. The plasma concentration of ibuprofen and renal functions were determined in both groups by the high-performance liquid chromatography (HPLC) method and cystatin-C (cys-C), respectively...
September 2017: Journal of Maternal-fetal & Neonatal Medicine
Laura Vargas Dornelles, Andréa Lúcia Corso, Rita de Cássia Silveira, Renato Soibelmann Procianoy
OBJECTIVE: To compare the efficacy of intravenous ibuprofen at high (20-10-10mg/kg/dose) and low doses (10-5-5mg/kg/dose) the closure of patent ductus arteriosus in preterm newborns. METHODS: A cohort study with historical control of newborns that received high- and low-dose intravenous ibuprofen, from 2010 to 2013 in a neonatal intensive care unit, for closure of the patent ductus arteriosus, documented by echocardiography. Secondary outcomes included the number of ibuprofen cycles, incidence of bronchopulmonary dysplasia, necrotizing enterocolitis, changes in renal function, and death...
May 2016: Jornal de Pediatria
Hannes Sallmon, Petra Koehne, Georg Hansmann
A patent ductus arteriosus (PDA) is associated with several adverse clinical conditions. Several strategies for PDA treatment exist, although data regarding the benefits of PDA treatment on outcomes are sparse. Moreover, the optimal treatment strategy for preterm neonates with PDA remains subject to debate. It is still unknown whether and when PDA treatment should be initiated and which approach (conservative, pharmacologic, or surgical) is best for individual patients (tailored therapies). This article reviews the current strategies for PDA treatment with a special focus on recent developments such as oral ibuprofen, high-dose regimens, and the use of paracetamol (oral, intravenous)...
March 2016: Clinics in Perinatology
Shahnaz Pourarian, Mehrdad Rezaie, Hamid Amoozgar, Ali-Mohammad Shakiba, Mohammad-Reza Edraki, Nima Mehdizadegan
BACKGROUND: Patent ductus arteriosus (PDA) is an important risk for heart failure due to left to right shunt in term neonates. OBJECTIVES: In this study, we evaluated the effect of high dose ibuprofen in closure of PDA in term neonates. PATIENTS AND METHODS: We used double dose ibuprofen (20 mg/kg, 10 mg/kg, and 10 mg/kg) for 3 - 30 day old term neonates with PDA who were admitted in the neonatal wards of Shiraz University of Medical Sciences...
August 2015: Iranian Journal of Pediatrics
İrfan Oğuz Şahin, Nurdan Dinlen Fettah, Mustafa Kara, Yaşar Demirelli, Kadir Şerafettin Tekgündüz, Canan Yolcu, Haşim Olgun, Naci Ceviz
OBJECTIVE: We aimed to investigate the efficacy of ibuprofen doses in closing patent ductus arteriosus (PDA) and the possibility of reducing drug-related complications by reducing dose number. METHODS: We performed a prospective study with 60 premature infants (≤33 weeks) who were treated with enteral ibuprofen for hsPDA. Echocardiographic examinations were performed before each dose. Treatment was stopped when PDA was closed and patients were followed for reopening and complications...
2016: Journal of Maternal-fetal & Neonatal Medicine
Shahnaz Pourarian, Faranak Takmil, Sirous Cheriki, Hamid Amoozgar
OBJECTIVE: The aim of this study is to compare the efficacy and possible adverse effects of the oral high-dose ibuprofen regimen to that of standard regimen in closing patent ductus arteriosus (PDA). STUDY DESIGN: This clinical trial study was performed from April 2012 to May 2013 on preterm infants with gestational age<37 weeks and postnatal age 3 to 7 days with echocardiographic diagnosis of hemodynamically significant PDA. These neonates were randomly assigned to two treatment groups that respectively received high dose (20-10-10 mg/kg/d) and standard dose (10-5-5 mg/kg/d) oral ibuprofen regimen for 3 days...
October 2015: American Journal of Perinatology
Daniëlla W E Roofthooft, Ingrid M van Beynum, Johan C A de Klerk, Monique van Dijk, John N van den Anker, Irwin K M Reiss, Dick Tibboel, Sinno H P Simons
UNLABELLED: Finding the optimal pharmacological treatment of a patent ductus arteriosus (PDA) in preterm neonates remains challenging. There is a growing interest in paracetamol as a new drug for PDA closure. In this prospective observational cohort study, we evaluated the effectiveness of intravenous paracetamol in closing a PDA in very low birth weight infants with a hemodynamically significant PDA who either did not respond to ibuprofen or had a contraindication for ibuprofen. They received high-dose paracetamol therapy (15 mg/kg/6 h intravenous) for 3-7 days...
November 2015: European Journal of Pediatrics
Arne Ohlsson, Rajneesh Walia, Sachin S Shah
BACKGROUND: Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer adverse effects. OBJECTIVES: To determine the effectiveness and safety of ibuprofen compared with indomethacin, other cyclo-oxygenase inhibitor, placebo or no intervention for closing a patent ductus arteriosus in preterm, low birth weight, or preterm and low birth weight infants...
February 18, 2015: Cochrane Database of Systematic Reviews
R Irmesi, M A Marcialis, J V D Anker, V Fanos
The primary objective of this review is to verify if there are differences in the diagnostic and therapeutic strategies in cases of PDA employed in different NICUs that might help explain the different percentages of duct closure, surgical ligation and outcome in these vulnerable patients. The secondary objective is to document if the selection of a specific NSAID and/or the way of administration are based on factors such as costs and local availability of drugs, as well as influenced by clinical and haemodynamic parameters, potential risks, local experience and the existing literature...
2014: Current Medicinal Chemistry
Mehmet Yekta Oncel, Sadik Yurttutan, Omer Erdeve, Nurdan Uras, Nahide Altug, Serife Suna Oguz, Fuat Emre Canpolat, Ugur Dilmen
OBJECTIVE: To compare the efficacy and safety of oral paracetamol and oral ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants. STUDY DESIGN: This prospective, randomized, controlled study enrolled 90 preterm infants with gestational age ≤ 30 weeks, birthweight ≤ 1250 g, and postnatal age 48 to 96 hours who had echocardiographically confirmed significant PDA. Each enrolled patient received either oral paracetamol (15 mg/kg every 6 hours for 3 days) or oral ibuprofen (initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours)...
March 2014: Journal of Pediatrics
Arne Ohlsson, Rajneesh Walia, Sachin S Shah
BACKGROUND: Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer side effects. OBJECTIVES: To determine the efficacy and safety of ibuprofen for closing a PDA in preterm and/or low birth weight infants. Seperate comparisons are presented for 1. ibuprofen (iv) compared with placebo; 2...
2013: Cochrane Database of Systematic Reviews
Gozde Kanmaz, Omer Erdeve, Fuat Emre Canpolat, Serife Suna Oğuz, Nurdan Uras, Nahide Altug, Ben Greijdanus, Uğur Dilmen
AIM: The aim of this study was to explore the effects of early oral ibuprofen administration on the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and define the association between serum ibuprofen levels and ductal closure. METHOD: Preterm infants with a gestational age of <28 weeks and/or birth weight of <1,000 g were randomized either to the intervention (ibuprofen prophylaxis) or control group. The intervention group received oral ibuprofen 10 mg/kg within 12-24 h after birth followed by 5 mg/kg at 24 and 48 h...
May 2013: European Journal of Clinical Pharmacology
Edmund V Capparelli
Patent ductus arteriosus (PDA) is a common complication in preterm infants. An intravenous (IV) cyclooxygenase (COX) inhibitor is the pharmacotherapy of choice. Concerns over adverse effects associated with the traditional treatment, IV indomethacin, have led to the investigation of other COX inhibitors to assist closure of PDA. IV ibuprofen lysine is a COX inhibitor that demonstrates similar efficacy to indomethacin with few adverse effects. In addition, IV ibuprofen lysine does not cause reductions in cerebral, renal, and mesenteric blood flow that can be seen with indomethacin, and thus ibuprofen therapy is not associated with reduced renal function...
July 2007: Journal of Pediatric Pharmacology and Therapeutics: JPPT: the Official Journal of PPAG
Franciszek Burdan, Elżbieta Starosławska, Justyna Szumiło
Over-the-counter cyclooxygenase inhibitors are used to relief fever and various types of acute pain like headache, toothache, earache, sore throat, as well as postoperative and menstrual ones. They are also major ingredients in cold and flu mixtures. Unlike well-known organ toxicological profile, their prenatal toxicity was not fully established. For a long time, acetaminophen was considered as a relatively safe antipyretic and analgesic drug during pregnancy. However, a new data indicate that it may increase the risk of cryptorchidism and asthma during childhood as well as preeclampsia, preterm birth, maternal phlebothrombosis and pulmonary embolism...
2012: Pharmacological Reports: PR
Mayoor Bhatt, Anna Petrova, Rajeev Mehta
The effect of patent ductus arteriosus (PDA) treatment with cyclooxygenase (COX) inhibitors (indomethacin [INDO] and ibuprofen [IBU]) on regional oxygenation requires further clarification. The authors hypothesized that both INDO and IBU reduce regional tissue oxygenation in preterm neonates with PDA but that the risk is not uniform for different tissues and other factors may contribute. Regional cerebral (rSO(2-C)), renal (rSO(2-R)), and mesenteric (rSO(2-M)) tissue oxygenation measured by near-infrared spectroscopy and peripheral arterial oxygen saturation measured by pulse oximetry were recorded simultaneously before, during, and after treatment with the first dose of INDO or IBU in very preterm-born infants with PDA...
December 2012: Pediatric Cardiology
Cathy Hammerman, Alona Bin-Nun, Michael Kaplan
Over recent years, the clinical approach to patency of the ductus arteriosus in the premature neonate has been the subject of intensive reevaluation. What had once been considered inherently obvious is no longer to be taken for granted. In this review we will focus on some of the controversies surrounding various aspects of the pharmacologic treatment regimens for patent ductus arteriosus closure. The pros and cons of prophylactic vs therapeutic indomethacin, of early vs late therapy, of high- vs low-dose indomethacin, of single vs multiple courses of treatment, and of ibuprofen vs indomethacin will be considered...
April 2012: Seminars in Perinatology
Udo Meißner, Raktima Chakrabarty, Hans-Georg Topf, Wolfgang Rascher, Michael Schroth
The patent ductus arteriosus (PDA) is associated with various complications of prematurity. Cyclooxygenase-inhibitors are the first-line intervention for closure of the PDA. However, the rates of PDA closure still are unsatisfactory. Therefore, an individual trial was performed by changing the strategy for treating neonates with ibuprofen to induce the closure of PDA. In a retrospective study, patients receiving 20, 10, and 10 mg/kg bodyweight ibuprofen (group 1) were compared by chart review with those receiving 10, 5, 5 mg/kg (group 2)...
April 2012: Pediatric Cardiology
C Dani, V Vangi, G Bertini, S Pratesi, I Lori, F Favelli, R Ciuti, A Bandinelli, C Martano, P Murru, H Messner, F Schena, F Mosca
Our aim was to assess the hypothesis that a high-dose regimen of ibuprofen is more effective than the standard-dose regimen in closing patent ductus arteriosus (PDA) without increasing adverse effects. Infants of gestational age <29 weeks, with respiratory distress syndrome (RDS) and echocardiographic evidence of significant PDA at 12-24 h of life, were randomized to receive a standard (10-5-5 mg/kg/day) or high-dose (20-10-10 mg/kg/day) course of ibuprofen. We studied 70 infants, 35 of whom received the standard dose of ibuprofen and the other 35 the high dose...
April 2012: Clinical Pharmacology and Therapeutics
Bernard Barzilay, Ilan Youngster, David Batash, Rimona Keidar, Shaul Baram, Michael Goldman, Matithiahu Berkovitch, Eli Heyman
BACKGROUND: Oral ibuprofen has been shown to be associated with excellent patent ductus arteriosus (PDA) closure rates and a favourable safety profile, but limited data exist regarding its pharmacokinetics in preterm infants. OBJECTIVE: To evaluate pharmacokinetic parameters of oral ibuprofen in preterm infants. METHODS: Plasma ibuprofen levels were determined at various time points, and pharmacokinetic profiles were calculated after a single dose of 10 mg/kg of oral ibuprofen...
March 2012: Archives of Disease in Childhood. Fetal and Neonatal Edition
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