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Paracetamol and preterm

Mehmet Yekta Oncel, Zeynep Eras, Nurdan Uras, Fuat Emre Canpolat, Omer Erdeve, Serife Suna Oguz
Objective This study aims to determine the effects of paracetamol versus ibuprofen treatment given to preterm infants for the pharmacological closure of patent ductus arteriosus (PDA) on neurodevelopmental outcomes at 18 to 24 months' corrected age. Method A follow-up study was conducted to evaluate the neurodevelopmental outcomes of preterm infants (gestational age ≤ 30 weeks) enrolled in a randomized controlled trial comparing oral paracetamol versus oral ibuprofen for the closure of PDA. The developmental assessment was done by using "Bayley Scales of Infant Development, Second Edition" at 18 to 24 months' corrected age...
April 10, 2017: American Journal of Perinatology
Abd El-Rahman El-Mashad, Heba El-Mahdy, Doaa El Amrousy, Marwa Elgendy
In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days...
February 2017: European Journal of Pediatrics
Bo Yang, Xiangyu Gao, Yi Ren, Yun Wang, Qinglin Zhang
The aim of the present study was to analyze the changes of plasma and urinary prostaglandin E2 (PGE2) levels in preterm infants with symptomatic patent ductus arteriosus (sPDA) treated with oral ibuprofen and acetaminophen. A total of 87 preterm infants with sPDA admitted to the Neonatal Ward of the Affiliated Xuzhou Hospital of Medical College of Southeast University from October, 2012 to June, 2015 were selected and randomly divided into the ibuprofen group (n=43, 10 mg/kg ibuprofen administered orally as initial dose, followed by 5 mg/kg during the first 24 and 48 h later) and acetaminophen group (n=44, 15 mg/kg acetaminophen administered orally once every 6 h for three days)...
October 2016: Experimental and Therapeutic Medicine
Enrico Valerio, Marta Rossella Valente, Sabrina Salvadori, Anna Chiara Frigo, Eugenio Baraldi, Paola Lago
UNLABELLED: Increasing recent evidence favors paracetamol use for patent ductus arteriosus (PDA) closure in preterms. Our study aims were (1) to assess efficacy and safety of intravenous (i.v.) paracetamol for PDA closure in a 23-32-week preterm population, as "first-line" (when traditional ibuprofen treatment was contraindicated) or "rescue" treatment (after ibuprofen failed), and (2) to identify predictors of PDA closure. The cumulative efficacy of consecutive cycles of i.v. paracetamol on PDA closure was confirmed after both "first-line" and "rescue" treatment, the overall PDA closure rates being, respectively, 56...
July 2016: European Journal of Pediatrics
Carlo Dani, Chiara Poggi, Fabio Mosca, Federico Schena, Gianluca Lista, Luca Ramenghi, Costantino Romagnoli, Enrica Salvatori, Maria Teresa Rosignoli, Paola Lipone, Alessandro Comandini
BACKGROUND: Patent ductus arteriosus (PDA) is one of most common complications in preterm infants. Although ibuprofen represents the first choice for the closure of PDA, this treatment can cause severe gastrointestinal and adverse renal effects and worsen platelet function. The successful closure of the PDA with paracetamol has been recently reported in several preterm infants, and the safety of paracetamol for this use has been suggested by the available data. METHODS/DESIGN: We present the design of a randomized, multicenter, controlled study, whose aim is to assess the effectiveness and safety of intravenous paracetamol in comparison to intravenous ibuprofen for the treatment of PDA in preterm infants...
April 2, 2016: Trials
Sindhu Sivanandan, Ramesh Agarwal
Opinions are divided regarding the management of a persistently patent ductus arteriosus (PDA). Some of the adverse effects associated with a large hemodynamically significant duct, including prolonged ventilation, pulmonary hemorrhage, bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), intraventricular hemorrhage (IVH), and mortality, indicate that active management of infants with large ductal shunts may sometimes be necessary. Indomethacin and ibuprofen are the two US FDA-approved cyclooxygenase (COX) inhibitors used for the closure of a ductus in preterm babies...
April 2016: Paediatric Drugs
Pankaj Kumar Mohanty, N Karthik Nagesh, Abdul Razak
We prospectively studied the effect of oral paracetamol in closing hemodynamically significant Patent ductus arteriosus in preterm infants (gestational age <32 weeks) where Ibuprofen was contraindicated. 29 of 40 neonates (72.5%) showed successful response while 11 (29.5%) failed to show any response. No major complications were seen.
February 2016: Indian Pediatrics
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
Mehmet Yekta Oncel, Omer Erdeve
Patent ductus arteriosus (PDA) is a common clinical condition in preterm infants which is inversely related to birth weight and gestational age. Cyclooxygenase inhibitors such as indomethacin and ibuprofen which block the prostaglandin conversion from arachidonic acid are the most commonly used drugs for ductal closure. This review focuses on the safety and efficacy oral medications in the management of PDA in preterm infants. Ibuprofen seems to be the first choice due to its higher safety profile, as it is associated with fewer gastrointestinal and renal side effects when compared to indomethacin...
February 8, 2016: World Journal of Clinical Pediatrics
Karel Allegaert, Mariska Y Peeters, Bjorn Beleyn, Anne Smits, Aida Kulo, Kristel van Calsteren, Jan Deprest, Jan de Hoon, Catherijne A J Knibbe
BACKGROUND: There is relevant between individual variability in paracetamol clearance in young women. In this pooled study, we focused on the population pharmacokinetic profile of intravenous paracetamol metabolism and its covariates in young women. METHODS: Population PK parameters using non-linear mixed effect modelling were estimated in a pooled dataset of plasma and urine PK studies in 69 young women [47 at delivery, 8/47 again 10-15 weeks after delivery (early postpartum), and 7/8 again 1 year after delivery (late postpartum), 22 healthy female volunteers with or without oral contraceptives]...
November 13, 2015: BMC Anesthesiology
Karina Claassen, Kirstin Thelen, Katrin Coboeken, Thomas Gaub, Jorg Lippert, Karel Allegaert, Stefan Willmann
Among pediatric patients, preterm neonates and newborns are the most vulnerable subpopulation. Rapid developmental changes of physiological factors affecting the pharmacokinetics of drug substances in newborns require extreme care in dose and dose regimen decisions. These decisions could be supported by in silico methods such as physiologically-based pharmacokinetic (PBPK) modeling. In a comprehensive literature search, the physiological information of preterm neonates that is required to establish a PBPK model has been summarized and implemented into the database of a generic PBPK software...
2015: Current Pharmaceutical Design
Antti Härmä, Outi Aikio, Mikko Hallman, Timo Saarela
OBJECTIVE: To determine whether intravenous paracetamol therapy is effective in pain therapy in premature infants. STUDY DESIGN: From June 2009 to December 2011, 108 infants born very low gestational age (<32 weeks) (VLGA) were given intravenous paracetamol before the age of 72 hours. The loading dose was 20 mg/kg followed by 7.5 mg/kg every 6 hours. One hundred ten VLGA infants admitted from October 2007 to May 2009 formed the comparison group who received no paracetamol...
January 2016: Journal of Pediatrics
Gianluca Terrin, Francesca Conte, Mehmet Yekta Oncel, Antonella Scipione, Patrick J McNamara, Sinno Simons, Rahul Sinha, Omer Erdeve, Kadir S Tekgunduz, Mustafa Dogan, Irena Kessel, Cathy Hammerman, E Nadir, Sadik Yurttutan, Bonny Jasani, Serdar Alan, Francesco Manguso, Mario De Curtis
OBJECTIVES: We performed a systematic review and meta-analysis of all the available evidence to assess the efficacy and safety of paracetamol for the treatment of patent ductus arteriosus (PDA) in neonates, and to explore the effects of clinical variables on the risk of closure. DATA SOURCE: MEDLINE, Scopus and ISI Web of Knowledge databases, using the following medical subject headings and terms: paracetamol, acetaminophen and patent ductus arteriosus. Electronic and manual screening of conference abstracts from international meetings of relevant organisations...
March 2016: Archives of Disease in Childhood. Fetal and Neonatal Edition
Swarup Kumar Dash, Nandkishor S Kabra, Bhupendra S Avasthi, Shobha R Sharma, Phalguni Padhi, Javed Ahmed
OBJECTIVE: To compare the efficacy of enteral paracetamol and intravenous indomethacin for closure of patent ductus arteriosus (PDA) in preterm neonates. DESIGN: Randomized controlled trial. SETTING: Level III neonatal intensive care unit. PARTICIPANTS: 77 preterm neonates with birth weight ?1500 g and PDA size ?1.5 mm, with left to right ductal flow with left atrium to aortic root ratio >1.5:1; diagnosed by 2D-Echo within first 48 hours of life...
July 2015: Indian Pediatrics
Sarah F Cook, Jessica K Roberts, Samira Samiee-Zafarghandy, Chris Stockmann, Amber D King, Nina Deutsch, Elaine F Williams, Karel Allegaert, Diana G Wilkins, Catherine M T Sherwin, John N van den Anker
OBJECTIVES: The aims of this study were to develop a population pharmacokinetic model for intravenous paracetamol in preterm and term neonates and to assess the generalizability of the model by testing its predictive performance in an external dataset. METHODS: Nonlinear mixed-effects models were constructed from paracetamol concentration-time data in NONMEM 7.2. Potential covariates included body weight, gestational age, postnatal age, postmenstrual age, sex, race, total bilirubin, and estimated glomerular filtration rate...
January 2016: Clinical Pharmacokinetics
Elke H J Krekels, Saskia van Ham, Karel Allegaert, Jan de Hoon, Dick Tibboel, Meindert Danhof, Catherijne A J Knibbe
PURPOSE: Based on recovered metabolite ratios in urine, it has been concluded that paracetamol glucuronidation may be up-regulated upon multiple dosing. This study investigates paracetamol clearance in neonates and infants after single and multiple dosing using a population modelling approach. METHODS: A population pharmacokinetic model was developed in NONMEM VI, based on paracetamol plasma concentrations from 54 preterm and term neonates and infants, and on paracetamol, paracetamol-glucuronide and paracetamol-sulphate amounts in urine from 22 of these patients...
September 2015: European Journal of Clinical Pharmacology
Emrah Utku Kabataş, Arzu Dursun, Serdar Beken, Dilek Dilli, Ayşegül Zenciroğlu, Nurullah Okumuş
OBJECTIVE: To investigate the efficacy of paracetamol in reducing pain during examination for retinopathy of prematurity (ROP) in preterm infants. METHODS: A total of 114 infants undergoing eye examination for retinopathy of prematurity screening were prospectively randomized. Topical anesthetic (Proparacaine; Alcaine® drop 0.5%) was applied 30 s before the eye examination in all the infants. The infants in the intervention group (Group 1, n = 58) received 15 mg/kg of oral paracetamol, 60 min before the examination...
January 2016: Indian Journal of Pediatrics
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
Asli Memisoglu, Zeynep Alp Ünkar, Nilufer Cetiner, Figen Akalın, Hulya Ozdemir, Hülya Selva Bilgen, Eren Ozek
OBJECTIVES: Indomethacin and ibuprofen are commonly used in the treatment of hemodynamically significant patent ductus arteriosus (hsPDA). These drugs are associated with serious adverse events, including gastrointestinal perforation, renal failure and bleeding. The role of paracetamol has been proposed for the treatment of PDA. METHODS: We report a series of 11 neonates (birth weight: 415-1580 g; gestational age: 23-30.3 weeks) who were treated with paracetamol for a hsPDA...
March 2016: Journal of Maternal-fetal & Neonatal Medicine
Arne Ohlsson, Prakeshkumar S Shah
BACKGROUND: In preterm newborns, the ductus arteriosus frequently fails to close and the infants require medical or surgical closure of the patent ductus arteriosus (PDA). A PDA can be treated surgically or medically with one of two prostaglandin inhibitors, indomethacin or ibuprofen. Case reports suggest that paracetamol may be an alternative for the closure of a PDA. Concerns have been raised that in neonatal mice paracetamol may cause adverse effects on the developing brain, and an association between prenatal exposure to paracetamol and later development of autism or autism spectrum disorder has been reported...
March 11, 2015: Cochrane Database of Systematic Reviews
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