Effect of age and birth weight on indomethacin pharmacodynamics in neonates treated for patent ductus arteriosus

Shaffer, Christopher L.; Gál, Péter; Ransom, J. Laurence; Carlos, Rita Q.; Smith, McCrae; Davey, Andrew M.; Dimaguila, Mary Ann V.T.; Brown, Yvonne; Schall, Stewart A.

doi:10.1097/00003246-200202000-00013

Cited by 63 publications

(43 citation statements)

References 17 publications

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“…The acute renal failure resolved by day 30. These results confirm the findings of other studies of acute renal failure in infants subsequent to the administration of indomethacin [7] and the only other published study of infants that reported long-term effects on renal function [9]. The retrospective study by Ojala et al [9] of 31 infants showed that kidney function was restored after 1 month following acute renal impairment.…”

Section: Discussionsupporting

confidence: 88%

“…Prostaglandins synthesized by the fetal/ neonatal kidney are responsible for maintaining adequate renal perfusion. Indomethacin-induced renal toxicity has been reported in up to 15% of treated infants [7]. The effect of indomethacin in reducing mesenteric and renal blood flow has been previously shown [8], while the longterm effects of indomethacin on renal function have only recently been examined.…”

Section: Introductionmentioning

confidence: 99%

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Indomethacin and renal impairment in neonates

Akima

Kent

Reynolds

et al. 2004

Pediatric Nephrology

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Renal impairment occurs in neonates receiving indomethacin for treatment of patent ductus arteriosus. Inhibition of cyclooxygenase within the neonatal kidney results in decreased prostaglandin synthesis and consequent reduction in renal perfusion. Indomethacin has been reported to cause short-term reduction in glomerular filtration that resolves after cessation of the drug. There is little information on the long-term effects of postnatal exposure to indomethacin. The aim of this study was to determine the incidence of renal impairment in infants treated with indomethacin in a single center, to determine whether there is evidence of renal impairment on day 30 or at discharge, and to identify risk factors for renal impairment. In a retrospective study, infants of less than 30 weeks completed gestation who received indomethacin to close the ductus arteriosus were matched with infants of the same gestation, birth weight, and severity of illness. Serum creatinine and glomerular filtration rates (GFR) were obtained prior to commencing indomethacin and on days 2, 7, and 30 following indomethacin administration. Acute renal failure was defined as an increase in creatinine of greater than 25%. Of those infants who were less than 30 weeks completed gestation, 24% had acute renal failure following indomethacin administration. There was a significant elevation in serum creatinine on day 2 and day 7 ( P<0.0001, P=0.002) and a decrease in GFR on day 2 and day 7 ( P<0.0001, P=0.01) following administration of indomethacin. Renal function had normalized by day 30 or discharge. The incidence of acute renal failure in neonates treated with indomethacin is clinically significant. Renal function returns to normal by day 30. Linear regression found no statistical significance for gestational age, day of indomethacin dosing, Clinical Risk Index for Babies (CRIB) score, and presence of an umbilical artery catheter to confound the effect of indomethacin on renal function.

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Section: Discussionsupporting

confidence: 88%

Section: Introductionmentioning

confidence: 99%

Indomethacin and renal impairment in neonates

Akima

Kent

Reynolds

et al. 2004

Pediatric Nephrology

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show abstract

“…Ibuprofen and indomethacin are the most commonly used drugs for this indication, and both of these drugs have adverse effects on the kidney. These effects may range from a small reduction in glomerular filtration rate to acute renal failure (Shaffer et al, 2002;Akima et al, 2004), which is more often noted in the less mature neonates (Ohlsson et al, 2013, Bagnoli et al, 2013.…”

Section: Introductionmentioning

confidence: 99%

Impact of Early Postnatal NSAID Treatment on Nephrogenesis in Wistar Rats

Bueters

Klaasen

Maicas

et al. 2015

Birth Defects Research Pt B

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“…This finding may be due to the overlapping mechanisms of these agents, but also likely relates to the common demographic risks for treatment failure mentioned above in both classes of medication. 15,16 To our knowledge, no randomized controlled trial to date addresses a patient population similar to that of the current report. The use of acetaminophen to facilitate ductal closure in this population is supported by numerous observational studies.…”

Section: Discussionmentioning

confidence: 80%

Acetaminophen for Patent Ductus Arteriosus in Extremely Low-Birth-Weight Neonates

Luecke

Liviskie

Zeller

et al. 2017

The Journal of Pediatric Pharmacology and Therapeutics

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OBJECTIVE Although non-steroidal anti-inflammatory drugs (NSAIDs) are the current standard therapy for the treatment of patent ductus arteriosus (PDA), many neonates have contraindications to receiving or may fail NSAID therapy. To avoid surgical ligation, these patients may benefit from an alternative therapy. The objective of this research is to report the efficacy and safety of acetaminophen for the treatment of PDA in a cohort of premature neonates. METHODS Demographics and clinical course were retrospectively evaluated for all neonates admitted during the study period who received acetaminophen for the treatment of PDA. Initial acetaminophen dosing was 15 mg/kg every 6 hours (88% intravenous). Efficacy was analyzed from ductal constriction on echocardiogram as well as need for further PDA treatment. Markers of hepatic and renal function as well as respiratory support and neonatal morbidities were evaluated to describe the safety of acetaminophen. RESULTS Forty-one neonates were identified with a median birth weight of 760 g (IQR 614–948 g) and median gestational age of 25 weeks (IQR 24–27 weeks). Treatment was initiated at a median postnatal age of 15 days (IQR 8–19 days) for a median duration of 7 days (IQR 6–10 days). Twenty-seven neonates (66%) required no further PDA treatment, with echocardiographic PDA closure documented in 10 neonates (24%) and reduced ductal size in 15 neonates (37%). No clinically significant adverse effects attributable to acetaminophen therapy were detected. CONCLUSIONS Most patients in this study responded to acetaminophen treatment for PDA, indicating that this therapy may be an option for extremely low-birth-weight neonates in order to avoid surgical ligation.

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Effect of age and birth weight on indomethacin pharmacodynamics in neonates treated for patent ductus arteriosus

Cited by 63 publications

References 17 publications

Indomethacin and renal impairment in neonates

Indomethacin and renal impairment in neonates

Impact of Early Postnatal NSAID Treatment on Nephrogenesis in Wistar Rats

Acetaminophen for Patent Ductus Arteriosus in Extremely Low-Birth-Weight Neonates

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