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Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infantsOhlsson A, Shah SS
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SummaryIbuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infantsIbuprofen may prevent patent ductus arteriosus (PDA), a common complication for preterm or very small babies, but more research is needed into possible serious adverse effects. PDA is a common complication for very preterm (premature) or very small babies. PDA is an open vessel that channels blood from the lungs to the body. It should close after birth, but sometimes remains open because of the baby's premature stage of development. PDA can lead to life-threatening complications. Indomethacin is successful in causing PDA closure, but can cause serious adverse effects. Another option is the drug ibuprofen, which can be given to try and prevent PDA. This updated review of trials found that ibuprofen can prevent PDA, but does not confer any other short-term or long-term benefits.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2010 Issue 1, Copyright © 2010 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This version first published online:
April 22. 2003 AbstractBackgroundPatent ductus arteriosus (PDA) complicates the clinical course of preterm infants and increases the risk of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), chronic lung disease (CLD) and death. The standard treatment to close a PDA is indomethacin. Indomethacin use is associated with renal, gastrointestinal and cerebral side-effects. Ibuprofen has been shown to be effective in closing a PDA without reducing blood flow velocity to the brain, gastrointestinal tract or kidneys. ObjectivesTo determine the effectiveness and safety of prophylactic ibuprofen compared to placebo/no intervention or other cyclo-oxygenase inhibitor drugs in the prevention of PDA in preterm infants. Search strategyRandomized controlled trials comparing prophylactic ibuprofen use with placebo/no intervention/indomethacin were identified by searching in January 2009 the Cochrane Central Register of Controlled Trial, MEDLINE, CINAHL and EMBASE. Selection criteriaRandomized or quasi-randomised controlled trials comparing use of ibuprofen with placebo/no intervention or other cyclo-oxygenase inhibitor drugs (indomethacin, mefenamic acid) for the prevention of PDA in preterm and/or low birth weight infants. Data collection and analysisData regarding the clinical outcomes including presence of PDA on day three, need for surgical ligation, need for rescue treatment with cyclo-oxygenase inhibitors, mortality, IVH, renal, pulmonary and gastrointestinal complications were extracted. Meta-analyses were performed and treatment estimates are reported as typical weighted mean difference (WMD), relative risk (RR), risk difference (RD) and, if statistically significant, number needed to treat to benefit (NNTB) or number needed to treat to harm (NNTH) along with their 95% confidence intervals (CI). Main resultsSix studies comparing prophylactic ibuprofen with placebo or no medication qualified for inclusion in this updated review, including two additional trials identified at this update (n = 197). Ibuprofen significantly decreased the incidence of PDA on day three [typical RR 0.36 (95% CI 0.28, 0.46); typical RD -0.27 (95% CI -0.33, -0.22); NNT 4 (95% CI 3, 5); six trials, n = 869], decreased the need for rescue treatment with cyclo-oxygenase inhibitors, and decreased the need for surgical ligation. However, the PDA had closed spontaneously by day three in 58% of the neonates in the control group. Ibuprofen negatively affects renal function (oliguria, increased creatinine) and may increase the risk of sepsis. No significant differences in mortality, intraventricular haemorrhage, pulmonary or intestinal complications were found. Authors' conclusionsProphylactic use of ibuprofen decreased the incidence of PDA, decreased the need for rescue treatment with cyclo-oxygenase inhibitors and decreased surgical closure. However, in the control group, the PDA closed spontaneously by day three in 58% of the neonates. Prophylactic treatment therefore exposes a large proportion of infants unnecessarily to a drug that has concerning renal side effects without conferring any important short-term benefits. Prophylactic treatment with ibuprofen is not recommended. Until long-term follow-up results are published from the trials included in this updated review, no further trials of prophylactic ibuprofen are recommended. |