Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants.
Abstract | BACKGROUND: OBJECTIVES: SEARCH STRATEGY: Randomized controlled trials comparing prophylactic ibuprofen use with placebo/no intervention/ indomethacin were identified by searching the Cochrane Controlled Trial Register (The Cochrane Library, Issue 4, 2002), MEDLINE (1966-November 2002), CINAHL (1982-November 2002), EMBASE (1980-November 2002), reference lists of published trials and abstracts published in Pediatric Research (1990-2002). No language restrictions were applied. SELECTION CRITERIA: DATA COLLECTION AND ANALYSIS: Data regarding the clinical outcomes including presence of PDA on day three and day seven, need for surgical ligation, need for rescue treatment with cyclo-oxygenase inhibitors, IVH, mortality, renal and gastrointestinal complications were extracted. Meta-analyses were performed using RevMan 4.1 and treatment estimates were reported as weighted mean difference (WMD), typical relative risk (RR), typical risk difference (RD) and, if statistically significant, number needed to treat (NNT) or number needed to harm (NNH), along with their 95% confidence intervals (CI). MAIN RESULTS: Four trials (n = 623) were included in the review. There was a statistically significant decrease in the incidence of PDA on day three in the ibuprofen group [typical RR 0.36 (95% CI 0.26, 0.49); typical RD -0.29 (95% CI -0.37, -0.21); NNT 3 (95% CI 3, 5); 3 trials, n = 488]. There was a significant increase in the serum creatinine levels in the ibuprofen group [WMD 0.11 mg/dl (95% CI 0.06, 0.17); 2 trials, n = 438]. There were no statistically significant differences in mortality, grade 3 or 4 IVH, CLD at 28 days or 36 weeks, need for surgical closure of PDA, NEC, GI hemorrhage, time to reach full feeds and urine output. One trial (Gournay 2002) (n = 135) reported on three infants in the ibuprofen group who developed pulmonary hypertension responsive to nitric oxide treatment. REVIEWER'S CONCLUSIONS: Prophylactic use of ibuprofen reduces the incidence of PDA. However, further trials, which address potential adverse effects including pulmonary hypertension, are needed. Such trials should include long-term neurodevelopmental outcomes. Trials comparing the effectiveness of prophylactic use of indomethacin versus ibuprofen may be warranted with particular reference to IVH, need for surgical ligation and neurodevelopmental outcome.
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Authors | S S Shah, A Ohlsson |
Journal | The Cochrane database of systematic reviews
(Cochrane Database Syst Rev)
Issue 2
Pg. CD004213
( 2003)
ISSN: 1469-493X [Electronic] England |
PMID | 12804505
(Publication Type: Journal Article, Meta-Analysis, Review, Systematic Review)
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Chemical References |
- Cyclooxygenase Inhibitors
- Enzyme Inhibitors
- Ibuprofen
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Topics |
- Cyclooxygenase Inhibitors
(therapeutic use)
- Ductus Arteriosus, Patent
(prevention & control)
- Enzyme Inhibitors
(therapeutic use)
- Humans
- Ibuprofen
(therapeutic use)
- Infant, Low Birth Weight
- Infant, Newborn
- Infant, Premature
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