A randomized trial of intravenous acetaminophen versus indomethacin for treatment of hemodynamically significant PDAs in VLBW infants

Davidson, Jennifer; Ferguson, John; Ivey, Evelyn Parker; Philip, Ranjit; Weems, Mark F.; Talati, Ajay J.

doi:10.1038/s41372-020-0694-1

Cited by 24 publications

(30 citation statements)

References 41 publications

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“…With potential for effective closure of the PDA and reduced adverse events (104), acetaminophen has become an appealing alternative to cyclooxygenase inhibitors (105), especially in infants with other morbidities easily aggravated by indomethacin/ibuprofen (106). However, a recent multicenter randomized control trial evaluating the effectiveness of IV acetaminophen over IV indomethacin in infants <32 weeks gestation with a birthweight ≤1,500 gms with a hemodynamically significant PDA by echocardiogram showed reduced effectiveness (5.9 vs. 55% closure rate) (107). In addition, a RCT evaluating the impacts of paracetamol compared to ibuprofen on neurodevelopment outcomes at 18-24 months corrected gestational age showed no significant difference (108).…”

Section: Medical Closure Of a Hemodynamically Significant Pdamentioning

confidence: 99%

Management of Patent Ductus Arteriosus in Premature Infants in 2020

et al. 2021

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The patent ductus arteriosus (PDA) is the most commonly found cardiac condition in neonates. While there have been several studies and thousands of publications on the topic, the decision to treat the PDA is still strongly debated among cardiologists, surgeons, and neonatologists. This is in part due to the shortage of long-term benefits with the interventions studied. Practice variations still exist within sub-specialties and centers. This article briefly summarizes the history, embryology and histology of the PDA. It also succinctly discusses the hemodynamic significance of a PDA which builds the framework to review all the available literature on PDA closure in premature infants, though not a paradigm shift just yet; it introduces transcatheter PDA closure (TCPC) as a possible armament to the clinician for this age-old problem.

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Section: Medical Closure Of a Hemodynamically Significant Pdamentioning

confidence: 99%

Management of Patent Ductus Arteriosus in Premature Infants in 2020

et al. 2021

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“…Of note, the study comparing IV APAP with IV indomethacin enrolled subjects with the lowest gestational age (25.5 weeks) of any published study thus far. 141 Collectively, 4 of the 10 RCTs that enrolled subjects born at >30 weeks of gestational age show a very consistent signal for safety as defined by the outcome of BPD (Figure 3). However, this signal is less reassuring and even concerning in the 6 trials where the average gestational age of the enrolled subjects is <30 weeks.…”

Section: Nicu Exposures: Underpowered To Determine Safety and Detect Harm Not Reassuringmentioning

confidence: 91%

“…139 Two trials have compared APAP with indomethacin, one using an PO formulation 140 and the other using IV. 141 In a population of infants born at 28.5 weeks of gestation, administration of PO APAP was not associated with increased BPD rates ($20%). 140 In contrast, rates of BPD were 65% in the indomethacin-exposed group and 82% following IV APAP exposure.…”

Section: Nicu Exposures: Underpowered To Determine Safety and Detect Harm Not Reassuringmentioning

confidence: 93%

“…Additional RCTs have not been included in these metaanalyses, primarily due to recent publication or to differences in comparison group. [137][138][139][140][141][142][143][144][145][146][147] Here, we have chosen to group studies based on the treatments being compared and have identified 4 types of trials. PO APAP vs PO ibuprofen, intravenous (IV) APAP vs PO ibuprofen, IV APAP vs IV ibuprofen, and APAP (PO or IV) vs IV indomethacin.…”

Section: Nicu Exposures: Underpowered To Determine Safety and Detect Harm Not Reassuringmentioning

confidence: 99%

“…Mean GA (enrolled subjects) % higher in APAP exposed % lower in APAP exposed Oncel 2014 135 Dang 2013 134 Balachander 2018 138 Yang 2016 136 Dash 2015 140 Davidson 2000 141 Al-lawama 2018 133 Kumar 2020 147 Dani 2020 139 El-Farrash 2019 145 Figure 3. Difference in BPD incidence plotted against average gestational age of enrolled subjects.…”

Section: Difference In Bpd Incidencementioning

confidence: 99%

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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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