Dataset Information

Efficacy and Safety of Paracetamol for Patent Ductus Arteriosus Closure in Preterm Infants: An Updated Systematic Review and Meta-Analysis.

ABSTRACT: Background: Indomethacin and ibuprofen, two commonly used prostaglandin inhibitors, are the drugs of choice for patent ductus arteriosus. However, paracetamol is an alternative choice when these drugs are ineffective or contraindicated. This study aimed to confirm paracetamol's efficacy and safety compared with those of other drugs or placebos for patent ductus arteriosus closure in premature infants. Methods: We conducted a literature search using the Cochrane Library, PubMed, CINAHL, and EMBASE databases for randomized controlled trials and quasi-randomized controlled trials. We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines to direct the process and PICO (P, population; I, intervention/interest; C, comparator; O, outcome) principle to constitute the theme. We combined the research data through qualitative summaries or meta-analyses. Results: The final analyses included 15 trials (N = 1,313). No significant differences were noted between paracetamol and ibuprofen except for shorter mean days needed for patent ductus arteriosus closure, lower risk of gastrointestinal bleeding, and hyperbilirubinemia. No significant difference existed between paracetamol and indomethacin. Oral paracetamol was more effective than placebo in infants weighing 1,501-2,500 g. Conclusions: Our study findings tentatively conclude that paracetamol can induce early patent ductus arteriosus closure without significant side effects but that its efficacy is not superior to that of indomethacin.

SUBMITTER: Xiao Y

PROVIDER: S-EPMC7039820 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Paracetamol for Patent Ductus Arteriosus Closure in Preterm Infants: An Updated Systematic Review and Meta-Analysis.

Xiao Yingqi Y Liu Hui H Hu Rujun R You Qiang Q Zeng Min M Jiang Xiaolian X

Frontiers in pediatrics 20200218

<b>Background:</b> Indomethacin and ibuprofen, two commonly used prostaglandin inhibitors, are the drugs of choice for patent ductus arteriosus. However, paracetamol is an alternative choice when these drugs are ineffective or contraindicated. This study aimed to confirm paracetamol's efficacy and safety compared with those of other drugs or placebos for patent ductus arteriosus closure in premature infants. <b>Methods:</b> We conducted a literature search using the Cochrane Library, PubMed, CIN ...[more]

PMID: 32133328

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Project description:BackgroundSymptomatic patent ductus arteriosus (PDA) is associated with mortality and morbidity in preterm infants. In these infants, prophylactic use of indomethacin, a non-selective cyclooxygenase inhibitor, has demonstrated short-term clinical benefits. The effect of indomethacin in preterm infants with a symptomatic PDA remains unexplored.ObjectivesTo determine the effectiveness and safety of indomethacin (given by any route) compared to placebo or no treatment in reducing mortality and morbidity in preterm infants with a symptomatic PDA.Search methodsWe used the standard search strategy of Cochrane Neonatal to search Cochrane Central Register of Controlled Trials (CENTRAL; 2020, Issue 7), in the Cochrane Library; Ovid MEDLINE(R) and Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Daily and Versions(R); and Cumulative Index to Nursing and Allied Health Literature (CINAHL), on 31 July 2020. We also searched clinical trials databases and the reference lists of retrieved articles for randomized controlled trials (RCTs) and quasi-RCTs.Selection criteriaWe included RCTs and quasi-RCTs that compared indomethacin (any dose, any route) versus placebo or no treatment in preterm infants.Data collection and analysisWe used the standard methods of Cochrane Neonatal, with separate evaluation of trial quality and data extraction by at least two review authors. We used the GRADE approach to assess the certainty of evidence for the following outcomes: failure of PDA closure within one week of administration of the first dose of indomethacin; bronchopulmonary dysplasia (BPD) at 28 days' postnatal age and at 36 weeks' postmenstrual age; proportion of infants requiring surgical ligation or transcatheter occlusion; all-cause neonatal mortality; necrotizing enterocolitis (NEC) (≥ Bell stage 2); and mucocutaneous or gastrointestinal bleeding.Main resultsWe included 14 RCTs (880 preterm infants). Four out of the 14 included studies were judged to have high risk of bias in one or more domains. Indomethacin administration was associated with a large reduction in failure of PDA closure within one week of administration of the first dose (risk ratio (RR) 0.30, 95% confidence interval (CI) 0.23 to 0.38; risk difference (RD) -0.52, 95% CI -0.58 to -0.45; 10 studies, 654 infants; high-certainty evidence). There may be little to no difference in the incidence of BPD (BPD defined as supplemental oxygen need at 28 days' postnatal age: RR 1.45, 95% CI 0.60 to 3.51; 1 study, 55 infants; low-certainty evidence; BPD defined as supplemental oxygen need at 36 weeks' postmenstrual age: RR 0.80, 95% CI 0.41 to 1.55; 1 study, 92 infants; low-certainty evidence) and probably little to no difference in mortality (RR 0.78, 95% CI 0.46 to 1.33; 8 studies, 314 infants; moderate-certainty evidence) with use of indomethacin for symptomatic PDA. No differences were demonstrated in the need for surgical PDA ligation (RR 0.66, 95% CI 0.33 to 1.29; 7 studies, 275 infants; moderate-certainty evidence), in NEC (RR 1.27, 95% CI 0.36 to 4.55; 2 studies, 147 infants; low-certainty evidence), or in mucocutaneous or gastrointestinal bleeding (RR 0.33, 95% CI 0.01 to 7.58; 2 studies, 119 infants; low-certainty evidence) with use of indomethacin compared to placebo or no treatment. Certainty of evidence for BPD, surgical PDA ligation, NEC, and mucocutaneous or gastrointestinal bleeding was downgraded for very serious or serious imprecision.Authors' conclusionsHigh-certainty evidence shows that indomethacin is effective in closing a symptomatic PDA compared to placebo or no treatment in preterm infants. Evidence is insufficient regarding effects of indomethacin on other clinically relevant outcomes and medication-related adverse effects.

Project description:Background: A meta-analysis published in 2015 showed a significant association between low platelet counts in the first day(s) of life and risk of patent ductus arteriosus (PDA). The meta-analysis pooled data from 11 studies cohorts (3,479 preterm infants). Objective: To update the meta-analysis by adding new studies on the topic and including other platelet parameters different from platelet counts. Methods: PubMed/Medline and Embase databases were searched. Random-effects risk ratios (RR) and differences in means (DM) and 95% confidence intervals (CI) were calculated. Results: We included 31 studies (7,638 infants). Meta-analysis showed that the risk of developing any PDA was significantly associated with platelet counts<150 × 109/L (11 studies, RR 1.58, 95% CI 1.28 to 1.95), and <100 x 109/L (7 studies, RR 1.61, 95% CI 1.14 to 2.28), but not <50 x 109/L (4 studies, RR 1.34, 95% CI 0.77 to 2.32). Risk of developing hemodynamically significant PDA (hsPDA) was significantly associated with platelet counts<150 x 109/L (12 studies, RR 1.33, 95% CI 1.09 to 1.63), and <100 x 109/L (7 studies, RR 1.39, 95% CI 1.06 to 1.82), but not <50 x 109/L (6 studies, RR 1.24, 95% CI 0.86 to 1.79). Infants with hsPDA had significantly lower mean platelet counts (19 studies, DM 22.0 x 109, 95% CI 14.9 to 29.1) and platelet mass (11 studies, DM 214.4, 95% CI 131.2 to 297.5) and significantly higher platelet distribution width (PDW, 9 studies, DM -0.53, 95% CI -1.01 to -0.05) than infants without hsPDA. Meta-analysis could not demonstrate significant differences in mean platelet volume (MPV). Conclusion: Compared to the previous analysis, this updated meta-analysis included 21 additional studies that provide stronger evidence of the association between low platelet counts and PDA/hsPDA. Other platelet parameters such as platelet mass and PDW are also associated with hsPDA risk. However, the low number of platelets may be an epiphenomenon associated with the maturity and clinical stability of preterm infants rather than a contributing factor in the pathogenesis of PDA.

Dataset Information

Efficacy and Safety of Paracetamol for Patent Ductus Arteriosus Closure in Preterm Infants: An Updated Systematic Review and Meta-Analysis.

Publications

Efficacy and Safety of Paracetamol for Patent Ductus Arteriosus Closure in Preterm Infants: An Updated Systematic Review and Meta-Analysis.

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