Efficacy of Paracetamol in Closure of Ductus Arteriosus in Infants under 32 Weeks of Gestation

Tofé, Inés; Ruiz-Gonzalez, Maria Dolores; Cañete, María Dolores; Pino, Asuncion; Rueda, Rosa Lorena; Parraga, Maria Jose; Pérez-Navero, Juan Luís

doi:10.3389/fped.2018.00025

Cited by 3 publications

(1 citation statement)

References 29 publications

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“…Tofe et al (19) demonstrated that paracetamol was effective in PDA closure in premature neonates under 32 weeks of gestation. They showed that paracetamol was comparable to ibuprofen and indomethacin in treating PDA, with a closure rate of 77.7% observed in the paracetamol group vs. 81.1% in the ibuprofen group.…”

Section: Discussionmentioning

confidence: 99%

Evaluating the Effectiveness of Ibuprofen from 2 Different Brands in Patent Ductus Arteriosus Closure in Preterm Neonates

Salehi,

Davoudi,

Abedini

et al. 2023

Mod Care J

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Background: Patent ductus arteriosus (PDA) is a common condition in premature babies, with a prevalence rate of 30 - 60%, and often requires medical or surgical intervention. Objectives: This study aimed to assess the effectiveness of 2 different brands of ibuprofen in PDA closure in preterm infants weighing less than 1500 g. Methods: This single-blind clinical trial study was performed on 75 premature neonates with PDA in the pediatric ward of Vali-Asr Hospital in Birjand from March 2014 to March 2019. Patients were treated with two brands of ibuprofen at doses of 10 mg/kg for the first day and 5 mg/kg for the second and third days (24 and 48 hours afterward). Before and three days after the last dose, the children were examined by pediatric cardiologist echocardiography. The data were input into SPSS version 23 and analyzed using descriptive statistics, such as mean and SD. Inferential statistics, such as the chi-square test, were also employed with a significance level of P-value < 0.05. Results: There was a significant difference between the rate of PDA closure, 78.8% in the Pedea group vs. 54.8% in the Ibuprofen group (P = 0.03). In the Ibuprofen group, there was no difference in drug efficacy in PDA closure between male and female neonates (P = 0.663). Also, in the Pedea group, there was a significant difference in terms of efficacy between male and female neonates (P = 0.049). No significant difference was observed in PDA closure between the two medications based on their sizes (P = 0.616 in small size, P = 0.266 in medium size, and P = 0.175 in large size). Conclusions: Pedea is more effective than Ibuprofen. It reduces complications and the need for surgery. However, there was no significant relationship between the two drugs based on the PDA sizes. Therefore, it seems logical to use the Iranian brand of ibuprofen, considering the benefits equal to the foreign one.

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Section: Discussionmentioning

confidence: 99%

Evaluating the Effectiveness of Ibuprofen from 2 Different Brands in Patent Ductus Arteriosus Closure in Preterm Neonates

Salehi,

Davoudi,

Abedini

et al. 2023

Mod Care J

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Acetaminophen and the Developing Lung: Could There Be Lifelong Consequences?

Wright

2021

The Journal of Pediatrics

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he use of acetaminophen (paracetamol, APAP) in the neonatal intensive care unit (NICU) has become ubiquitous. Between 2005 and 2010, APAP was the 15th most common pharmacologic exposure among infants admitted to the Pediatrix-affiliated NICUs in the US. 1 Over nearly the same period of time, a significant increase in the use of APAP was reported in German NICUs, occurring in 8.1% of all infants with very low birth weights by 2010. 2 Since 2010, multiple reports indicate increasing APAP use in NI-CUs around the world. Data gathered in 2017-2018 from nearly 30 000 French infants showed that APAP was the third most commonly administered medication behind vitamin K and vitamin D and was given to >65% of all infants born at less than 27 weeks of gestation. 3 It is likely that this rapid increase in APAP exposure is primarily driven by the desire to provide analgesia and limit opioid exposure. In fact, one French NICU reported that by 2012-2013, nearly 95% of patients in the NICU postsurgery were administered APAP. 4 These data have been interpreted as demonstrating that "paracetamol is somehow a 'rising star' in NICU pain management." 5 The introduction of APAP into the NICU led to the chance observation that administration was temporally associated with closure of the patent ductus arteriosus (PDA). 6 In the time since this case series was published in 2011, the rise in annual publications in PubMed.gov demonstrate the rapidly growing interest in this pharmacologic approach to PDA treatment (Figure 1). Multiple case series, cohort studies, and ultimately randomized controlled trials (RCTs) evaluating APAP for PDA followed, and these have been summarized in a number of comprehensive reviews. [7][8][9][10][11][12][13] Based on the available data, a 2020 Cochrane review by Ohlsson and Shah concluded that moderate-quality evidence demonstrated that APAP is as effective as ibuprofen to treat PDA. 14 However, this review also noted that the results from the more than 19 registered and ongoing trials are necessary before any "recommendations for the possible routine use of paracetamol in the newborn population can be made." Specifically, the paucity of data

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Paracetamol for Closure of Patent Ductus Arteriosus in Preterm Babies Born Before 32-Week Gestational Age

Mahmoud

Asklany

2021

Journal of Clinical Neonatology

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Background: It remains unclear which treatment approach is most advantageous for closure of patent ductus arteriosus (PDA) in preterm infants. Despite the presence of previous trials and meta-analysis, a correct and univocal strategy for closure of PDA is still under debate. Till now, standard medical treatment for PDA closure has been indomethacin/ibuprofen, percutaneous transcatheter closure, or surgical ligation. Up to date, new strategies have been reported with paracetamol. The aim of this study was to present our experience with intravenous (IV) and oral paracetamol for closing PDA in preterm neonates born before 32-week gestational age (GA). Patients and Methods: We conducted a prospective study in a neonatal intensive care unit (NICU) from a tertiary hospital in Minia University; Egypt. Eighty-seven preterm neonates born before 32-week GA with hemodynamically significant PDA (hsPDA) were enrolled. They received 15 mg/kg/6 h for 5 days IV or oral paracetamol for ductal closure. Our NICU guidelines before the current study state that only hsPDA is treated with oral ibuprofen based on the decision of the neonatologist after discussion with pediatric cardiologist. The study aims to vary the practice to use IV or oral paracetamol instead of ibuprofen to avoid side effects of nonsteroidal drugs in preterm babies. Results: During the study period, 140 babies <32 weeks admitted to the NICU assessed for eligibility to the study, 87 of them received IV or oral paracetamol for the treatment of hsPDA for a total of 5 days. Forty-five babies received IV paracetamol, while 42 received oral form with closure rate of 82.22% and 80.95%, respectively. Successful closure on paracetamol was achieved in 71 of 87 babies (81.6%). Conclusion: This study concluded that paracetamol is not only an alternative treatment in closing PDA but also may be the treatment of choice in future.

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Efficacy of Paracetamol in Closure of Ductus Arteriosus in Infants under 32 Weeks of Gestation

Cited by 3 publications

References 29 publications

Evaluating the Effectiveness of Ibuprofen from 2 Different Brands in Patent Ductus Arteriosus Closure in Preterm Neonates

Evaluating the Effectiveness of Ibuprofen from 2 Different Brands in Patent Ductus Arteriosus Closure in Preterm Neonates

Acetaminophen and the Developing Lung: Could There Be Lifelong Consequences?

Paracetamol for Closure of Patent Ductus Arteriosus in Preterm Babies Born Before 32-Week Gestational Age

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